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McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name
McKesson FDA UDI
Generic Name
Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
Device Name
MASK, PEDIATRIC FACE WITH EARLOOP FDA UDI
Model / Reference
16-1000 FDA UDI
Description
MASK, PEDIATRIC FACE WITH EARLOOP FDA UDI

Identifiers

Primary DI / UDI-DI
10612479230870 FDA UDI
FDA Product Code
FXX FDA UDI
OXZ FDA UDI
GMDN Term
Surgical/medical respirator, non-antimicrobial, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 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

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

Category: Surgical/medical respirator, non-antimicrobial, single-use

McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical respirator, non-antimicrobial, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mckesson Medical-Surgical Inc.

Sources (1)

  • FDA UDI d170c0cd-ec80-4f6b-8f3d-e2d3f12c6773 33 fields · synced May 30, 2026