FDA.reportPublic FDA data

Tourniquet System

Primary DI
06975218190352
Brand
Tourniquet System
Company
Anetic Aid USA LLC
Model
Single-use Sterile Tourniquet Cuff - Large Leg - C
Catalog number
40878
Published
2023-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KCYTourniquet, Pneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975218190352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975218190352069752181903526975218190352

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, single-useA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083649158
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051995000006QA3 Patient Stretcher SystemQA3 Patient Stretcher211102023-09-11
05051995000013QA3 Patient Stretcher SystemQA3 Emergency Stretcher211202023-09-11
05051995000020QA4 Mobile Surgery SystemQA4 Mobile Surgery Platfrom213002023-09-11
05051995000150QA3 Patient Stretcher SystemQA3 DRIVE Patient Stretcher211122023-09-11
05051995000167QA3 Patient Stretcher SystemQA3 DRIVE Powered Patient Stretcher211142023-09-11
05051995000181QA3 Patient Stretcher SystemQA3 DRIVE Emergency Stretcher211222023-09-11
05051995000198QA3 Patient Stretcher SystemQA3 DRIVE Powered Emergency Stretcher211242023-09-11
05051995000204QA3 Patient Stretcher SystemQA3 Powered Emergency Stretcher211242023-09-11
05051995004912QA3 Patient Stretcher SystemQA3 Ophthalmic Stretcher211182023-09-11
05051995008712QA3 Patient Stretcher SystemQA3 <800> DRIVE Powered Patient Stretcher211152023-09-11
05051995008729QA3 Patient Stretcher SystemQA3 Treatment Stretcher211172023-09-11
05060228640537Tourniquet SystemAT4 Electronic Tourniquet400802023-09-11
06975218190239Tourniquet SystemSingle-use Sterile Tourniquet Cuff - Pediatric408002023-09-11
06975218190253Tourniquet SystemSingle-use Sterile Tourniquet Cuff - Leg408602023-09-11
06975218190277Tourniquet SystemSingle-use Sterile Tourniquet Cuff - Arm408202023-09-11
06975218190291Tourniquet SystemSingle-use Sterile Tourniquet Cuff - Large Arm / S408402023-09-11
06975218190314Tourniquet SystemSingle-use Sterile Tourniquet Cuff - Leg - Conical408682023-09-11
06975218190338Tourniquet SystemSingle-use Sterile Tourniquet Cuff - Large Leg408702023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489106015MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106022MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106039MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106077MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106084MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106091MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106107MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106114MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106121MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106138MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106145MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106152MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106169MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106176MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106183MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106190MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106206MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106213MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106220MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106237MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106244MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10080196374854MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
10080196379187MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
08809802644052Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644069Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644076Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644083Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16