Headgear disp., soft farbic, sm.

FDA UDI

Class I (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: Headgear disp.,soft farbic,sm. FDA UDI
Generic Name: Anaesthesia mask strap, reusable FDA UDI
Model / Reference: MP01559 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675041047 FDA UDI
FDA Product Code: BSJ FDA UDI
GMDN Term: Anaesthesia mask strap, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Anaesthesia mask strap, reusable

Headgear disp., soft farbic, sm. by Drägerwerk AG & Co. KGaA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia mask strap, reusable.

Sunset Ruby Style Chin Strap – Fully Adjustable — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
Carex Health Brands — COMPASS HEALTH BRANDS CORP. · Class I
Underarm Straps — Intersurgical Incorporated · Class I
Universal Neoprene Chinstrap — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
BreatheWear Halo Chinstrap by Marpac — Marpac, Inc. · Class I
Sunset Halo Style Chinstrap — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
Universal Headgear — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
Sunset Ruby Style Chin Strap - Medium — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Drägerwerk AG & Co. KGaA

Sources (1)

FDA UDI 4fca56e6-421c-4fe6-b54d-c90ab5cd6f9a 33 fields · synced May 30, 2026