Device
3537
Manufacturer
TELEFLEX INCORPORATED
Model: 3537 Catalog: 3537 DI: 10841156111939 Status: Update MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-04 Current Version: 2026-05-15
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 2
Record Key: e993b10d-0c4b-4dae-8210-4e45ac22b825
Distribution Status: In Commercial Distribution
DUNS Number: 002348191
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Item #1 - Pkg Type: BX
Item #1 - Device ID: 20841156111936
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10841156111939
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10841156111939
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 65119
Name: Vascular puncture haemostasis arm clamp/band, single-use
Definition:
A semi-flexible, adjustable, clamp or band/strap device designed for application over an arterial/venous/fistula needle-puncture site on a patient’s arm to provide uniform pressure and achieve haemostasis. Commonly used on haemodialysis patients, some types are referred to as fistula clamps. This is a single-use device.
FDA Product Codes
DXC
CLAMP, VASCULAR