Konmed

FDA UDI

Class I (US FDA UDI)

by Shenzhen Konmed Technology Co., Ltd.

Identity

Trade Name: Konmed FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name: This Disposable shields roll with a low resistance filter that fits over manikin face; It can be protection students from insanitary risks when they're sharing a manikin in the CPR training class. The baterial filter efficiency is more than 95%,as same as N95 mask; Provide the customize logo and package service. FDA UDI
Model / Reference: CPR Mask in roll Model:KM-110 FDA UDI
Description: This Disposable shields roll with a low resistance filter that fits over manikin face; It can be protection students from insanitary risks when they're sharing a manikin in the CPR training class. The baterial filter efficiency is more than 95%,as same as N95 mask; Provide the customize logo and package service. FDA UDI

Identifiers

Primary DI / UDI-DI: 06970935830338 FDA UDI
FDA Product Code: BYP FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5620 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

Yes

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary resuscitation mask, single-use

Konmed by Shenzhen Konmed Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Shenzhen Konmed Technology Co., Ltd.

Sources (1)

FDA UDI 82817981-8c11-4488-adff-b8ea57e03268 33 fields · synced May 29, 2026