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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Pulmonary resuscitator, manual, single-use FDA UDI
Device Name
DBD-CLIPS, FULL FACE NIV MASK FDA UDI
Model / Reference
HCSNIVCLIP FDA UDI
Description
DBD-CLIPS, FULL FACE NIV MASK FDA UDI

Identifiers

Catalog Number
HCSNIVCLIP FDA UDI
Primary DI / UDI-DI
10193489021486 FDA UDI
FDA Product Code
CBK FDA UDI
GMDN Term
Pulmonary resuscitator, manual, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5895 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulmonary resuscitator, manual, single-use

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary resuscitator, manual, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI d9042bf4-0e4b-4471-89ff-cc4487536d6b 36 fields · synced May 30, 2026