← Back to catalogue

Anaesthetic Face Mask

FDA UDI

Class I (US FDA UDI)

by Enter Medical Corporation

Identity

Trade Name
Anaesthetic Face Mask FDA UDI
Generic Name
Resuscitator face mask, single-use FDA UDI
Device Name
Anaesthetic Face Mask FDA UDI
Model / Reference
PN-0506 FDA UDI
Description
Anaesthetic Face Mask FDA UDI

Identifiers

Primary DI / UDI-DI
04719872109853 FDA UDI
FDA Product Code
BSJ FDA UDI
GMDN Term
Resuscitator face mask, single-use 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Resuscitator face mask, single-use

Anaesthetic Face Mask by Enter Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resuscitator face mask, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Enter Medical Corporation

Sources (1)

  • FDA UDI 51e99b90-0da9-496c-949e-e2f13b258fdb 33 fields · synced May 30, 2026