Mizzy Comfort Cushion

FDA UDI

Class I (US FDA UDI)

by Keystone Industries

Identity

Trade Name: Mizzy Comfort Cushion FDA UDI
Generic Name: Anaesthesia mask strap, reusable FDA UDI
Device Name: Head Strap (2 Per Bag) FDA UDI
Model / Reference: 6070155 FDA UDI
Description: Head Strap (2 Per Bag) FDA UDI

Identifiers

Catalog Number: 6070155 FDA UDI
Primary DI / UDI-DI: H66860701551 FDA UDI
FDA Product Code: BTK FDA UDI
GMDN Term: Anaesthesia mask strap, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5560 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

Yes

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Anaesthesia mask strap, reusable

Mizzy Comfort Cushion by Keystone Industries — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Anaesthesia mask strap, reusable.

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Universal Neoprene Chinstrap — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
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Universal Headgear — 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

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Manufacturer

Manufacturer: Keystone Industries

Sources (1)

FDA UDI 6b11c198-6eb4-479c-b40a-f79775c029d5 35 fields · synced Jun 9, 2026