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Resuscitation Face Mask Single Use Round Silicone Neonatal Size 0

FDA UDI

Class I (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
Resuscitation Face Mask Single Use Round Silicone Neonatal Size 0 FDA UDI
Generic Name
Cardiopulmonary resuscitation mask, single-use FDA UDI
Model / Reference
NF-160-10U FDA UDI

Identifiers

Primary DI / UDI-DI
00854401006570 FDA UDI
FDA Product Code
BYG FDA UDI
GMDN Term
Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5580 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

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

No

FDA UDI

Resuscitation Face Mask Single Use Round Silicone Neonatal Size 0 by Flexicare Medical Limited — Class I — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flexicare Medical Limited

Sources (1)

  • FDA UDI 9e4cccd3-12c6-473e-8ce5-9039c79a60ef 33 fields · synced May 31, 2026