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Comfort Band

FDA UDI

Class I (US FDA UDI)

by Tz Medical, Inc.

Identity

Trade Name
Comfort Band FDA UDI
Generic Name
Vascular puncture haemostasis arm clamp/band, single-use FDA UDI
Device Name
Comfort Band, Sterile, 14” – Blue FDA UDI
Model / Reference
CB-8514B FDA UDI
Description
Comfort Band, Sterile, 14” – Blue FDA UDI

Identifiers

Primary DI / UDI-DI
10811331010173 FDA UDI
FDA Product Code
MHW FDA UDI
GMDN Term
Vascular puncture haemostasis arm clamp/band, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5075 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vascular puncture haemostasis arm clamp/band, single-use

Comfort Band by Tz Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular puncture haemostasis arm clamp/band, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tz Medical, Inc.

Sources (1)

  • FDA UDI 0e64c321-284e-4321-a510-8877840152b1 33 fields · synced May 31, 2026