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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Ultrasonic nebulizing system FDA UDI
Device Name
DBD-DETECTOR,CO2,PEDIATRIC FDA UDI
Model / Reference
HCSCO2P FDA UDI
Description
DBD-DETECTOR,CO2,PEDIATRIC FDA UDI

Identifiers

Catalog Number
HCSCO2P FDA UDI
Primary DI / UDI-DI
10888277660182 FDA UDI
510(k) Number
K072220 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
Ultrasonic nebulizing system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasonic nebulizing systemResuscitator face mask, single-use

Medline by Medline Industries, Inc. — Class II — 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

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Manufacturer

Sources (1)

  • FDA UDI e135e191-52da-4599-94d4-2e46382759aa 37 fields · synced May 31, 2026