FDA UDI In Commercial Distribution 🇺🇸 United States

Disposable Tourniquet Cuff

DI: 06976514770637 · Model: 18"X4"; 20-4610 · Zhejiang Longyou Lande Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Disposable Tourniquet Cuff
Primary DI
06976514770637
Version / Model
18"X4"; 20-4610
Company Name
Zhejiang Longyou Lande Medical Technology Co., Ltd.
Labeler DUNS
541228485
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-12-26
Public Version
1
Public Version Date
2024-01-03
Public Version Status
New
Public Device Record Key
916bd31c-5bba-4c66-9431-a63ce622358a

Device Description

A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KCY Tourniquet, Pneumatic

GMDN Terms

Code Name
35925 Tourniquet cuff, single-use

Identifiers

Type ID
Package 16976514770634
Primary 06976514770637
Package 26976514770631