Hemorrhage Stops Here™
Hemorrhage Stops Here™
Device Classification Name
510(K) Number
Device Name
Device Registrant
Regulation Number
Classification Product Code
510(K) Decision Date
Classification Advisory Committee
Weight
Cube
Distributor
Distributor Contact Information
Distributor Web Site
Part Number
CAGE Code
Description
510(K) Number
Device Name
Device Registrant
Regulation Number
Classification Product Code
510(K) Decision Date
Classification Advisory Committee
Weight
Cube
Distributor
Distributor Contact Information
Distributor Web Site
Part Number
CAGE Code
Description
Clamp, Vascular
K112384
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET
COMPRESSION WORKS LLC
21 CFR 870.4450
DXC
10/18/2011
Cardiovascular
17 oz (482 g)
0.0833 ft3
Speer Operational Technologies
(888) 427-5231
http://www.speeroptech.com
AAT001
63M48
The Abdominal Aortic & Junctional Tourniquet (AAJT) utilizes a wedge shaped bladder that when inflated pushes in on the lower abdomen, groin and axilla compressing vasculature to stop arterial bleeding in junctional hemorrhage. The device is designed to stay in place during any movement of the casualty and to stop all blood flow to the pelvis and lower limbs.
K112384
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET
COMPRESSION WORKS LLC
21 CFR 870.4450
DXC
10/18/2011
Cardiovascular
17 oz (482 g)
0.0833 ft3
Speer Operational Technologies
(888) 427-5231
http://www.speeroptech.com
AAT001
63M48
The Abdominal Aortic & Junctional Tourniquet (AAJT) utilizes a wedge shaped bladder that when inflated pushes in on the lower abdomen, groin and axilla compressing vasculature to stop arterial bleeding in junctional hemorrhage. The device is designed to stay in place during any movement of the casualty and to stop all blood flow to the pelvis and lower limbs.
Technical Specifications
Dimensions
Pressurization
Deflation
Gauge Accuracy
RF Weld Air Retention
Operating Environment
Mildew Resistance
Blocking (bladder self-adhesion)
Low Temperature damage
Pressurization
Deflation
Gauge Accuracy
RF Weld Air Retention
Operating Environment
Mildew Resistance
Blocking (bladder self-adhesion)
Low Temperature damage
9” (w) x 8” (d) x 2” (h) (23cm x 20cm x 5cm)
Manual, by inflator bulb
Built-in 300 mm Hg relief valve and thumb screw valve
Pressure: 3mmHg
20 PSI (1034 mm Hg) (138 kPa)
-40° C to +85° C
Fabric Passes Mil-STD.810 F
No Blocking at 180° F for 30 min
No material defect at -60° F for 4 hours
Manual, by inflator bulb
Built-in 300 mm Hg relief valve and thumb screw valve
Pressure: 3mmHg
20 PSI (1034 mm Hg) (138 kPa)
-40° C to +85° C
Fabric Passes Mil-STD.810 F
No Blocking at 180° F for 30 min
No material defect at -60° F for 4 hours
Clinical Specifications
Indications
Hemorrhage control device to be used in casualties with pelvic, inguinal or leg bleeding and axilla hemorrhage. The device is utilized for quick control of hemorrhage for initial assessment and for definitive treatment of severe bleeding in these areas.
Absolute Contraindications
Pressure to occlude aortic flow
Pressure when gauge is green
Relief Pressure
Pressure to occlude aortic flow
Pressure when gauge is green
Relief Pressure
Known abdominal aortic aneurysm and Pregnancy
230 mm Hg
250 mm Hg
300 mm Hg
230 mm Hg
250 mm Hg
300 mm Hg
Engineering Parameters
Materials – Hard Components
Materials – Bladder
Materials – Belt
Materials – Tubing
Materials – Gauge
Materials – Bulb
Manufacturer Certification
Engineered in the USA
Made in the USA
Materials – Bladder
Materials – Belt
Materials – Tubing
Materials – Gauge
Materials – Bulb
Manufacturer Certification
Engineered in the USA
Made in the USA
Long carbon fiber reinforced thermoplastics
Coated 200 Denier for RF welding
Nylon
PVC (3/16 ID, 5/16 OD, SHORE A70)
Plastic Inflation Gauge, 150-300 mmHg, with 300 mm relief
PVC, 5 oz inline pump with check valve and air release valve
ISO 9000, FDA Registered
All components
All components, final assembly and packaging
Coated 200 Denier for RF welding
Nylon
PVC (3/16 ID, 5/16 OD, SHORE A70)
Plastic Inflation Gauge, 150-300 mmHg, with 300 mm relief
PVC, 5 oz inline pump with check valve and air release valve
ISO 9000, FDA Registered
All components
All components, final assembly and packaging
No Accessories available for the AAT
Packaging and Shipping
- Single Unit
- 5 Unit Box
- 25 Unit Box
W x D x H (inches)
9 x 8 x 2
12 x 10 x 6
32 x 12 x 12
9 x 8 x 2
12 x 10 x 6
32 x 12 x 12
Cube (cubic feet)
0.083
0.416
2.666
0.083
0.416
2.666
WT (lb.)
1.06
6.1
31.2
1.06
6.1
31.2
NSN
6515-01-616-4999
