B.braun

FDA UDI

Class II (US FDA UDI)

by B.Braun Avitum AG

Identity

Trade Name: B.BRAUN FDA UDI
Generic Name: Blood pressure cuff, reusable FDA UDI
Device Name: ABPM Cuff (medium) (7102771) FDA UDI
Model / Reference: 7102771 FDA UDI
Description: ABPM Cuff (medium) (7102771) FDA UDI

Identifiers

Catalog Number: 7102771 FDA UDI
Primary DI / UDI-DI: 04039239040859 FDA UDI
510(k) Number: K083460 FDA UDI
K963440 FDA UDI
FDA Product Code: KDI FDA UDI
GMDN Term: Blood pressure cuff, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood pressure cuff, reusable

B.braun by B.Braun Avitum AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood pressure cuff, reusable.

Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
Orbit-K — SUNTECH MEDICAL, INC. · Class II
Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
MDF® — MDF Instruments Medifriend Inc. · Class II
Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc. · Class II
Welch Allyn, Inc. — Welch Allyn, Inc. · Class II

Cleared under the same submission

K083460 also covers:

K963440 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: B.Braun Avitum AG

Sources (1)

FDA UDI f7b6397d-8913-45ae-80bd-60806e1b0560 37 fields · synced Jun 6, 2026