FDA.reportPublic FDA data

TK-4L Elastic Tourniquet

Primary DI
00857048006323
Brand
TK-4L Elastic Tourniquet
Company
H&H MEDICAL CORPORATION
Model
1
Catalog number
TK-4L
Device description
TK-4L Tourniquet, an elastic tourniquet designed for larger limbs with one S-Hook and one Carabiner end, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss. Strap color is black
Published
2020-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857048006323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857048006323008570480063238570480063230857048006323

GMDN Terms#

Term, Definition table
TermDefinition
Arm/leg tourniquet, single-useA non-sterile strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
804-642-3663info@gohandh.com

Regulatory Flags#

DUNS number
072656713
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857048006064H&H Big Cinch Abdominal Bandage1BC012020-07-10
00857048006095H-Bandage Compression Dressing, Flat Fols1HBFF012020-07-10
00857048006101Thin H Compression Bandage, Standard Fold1HBT012020-07-10
00857048006118Thin H Compression Dressing, Flat Fold1HBTF2020-07-10
00857048006125Mini Compression Bandage1HHMCB012020-07-10
00857048006057H&H Situation Instrument Tray Kit1HHSIT012020-07-06
00857048006392SWAT-T Elastic Tourniquet, Black1SWAT-T-BLK-EA2020-12-31
00857048006422SWAT-T Elastic Tourniquet, Orange1SWAT-T-BLK-EA2020-12-31
00857048006316TK-4 Elastic Tourniquet1TK-42020-12-31
00857048006484H&H Combat Medic Tape1CMRT012020-12-31
00857048006361H&H Compressed Gauze1HHPG2020-12-31
00857048006521H&H Flat Compressed Gauze1HHPF2020-12-31
00857048006538H&H TACgauze Wound Wrapping Gauze1TACG022020-12-31
00857048006545H&H MiniTAC Wound Wrapping Gauze1HHMTG012020-12-31
00857048006088H-Bandage Compression Dressing - Rolled1HB012020-07-10
00857048006583H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006590H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006132Bolin Chest Seal6BCS012020-12-31
00857048006552H&H 30fr Nasopharyngeal Airway, Each1.0HHNPA-EA2020-12-31
00857048006286Bolin Chest Seal6BCS012020-12-31

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