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Res-Cue KeyFace Shield

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name
Res-Cue KeyFace Shield FDA UDI
Generic Name
Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name
Red Nylon Bag w/ RescueKey FDA UDI
Model / Reference
248404104 FDA UDI
Description
Red Nylon Bag w/ RescueKey FDA UDI

Identifiers

Catalog Number
248404104 FDA UDI
Primary DI / UDI-DI
05707480031924 FDA UDI
FDA Product Code
BTM FDA UDI
GMDN Term
Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5915 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Res-Cue KeyFace Shield by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambu A/S

Sources (1)

  • FDA UDI 2c95d684-b0ef-4371-94ca-842c42362a62 36 fields · synced Jun 8, 2026