Medline Industries, Inc.

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: MEDLINE INDUSTRIES, INC. FDA UDI
Generic Name: Nebulizing system delivery set, single-use FDA UDI
Device Name: COMPRESSOR,NEBULIZER, CHARACTER, MONKEY FDA UDI
Model / Reference: HCSMONKEY FDA UDI
Description: COMPRESSOR,NEBULIZER, CHARACTER, MONKEY FDA UDI

Identifiers

Catalog Number: HCSMONKEY FDA UDI
Primary DI / UDI-DI: 00884389106894 FDA UDI
FDA Product Code: BTI FDA UDI
CAF FDA UDI
GMDN Term: Nebulizing system delivery set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.6250 FDA UDI
868.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nebulizing system delivery set, single-use

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medline Industries, Inc.

Sources (1)

FDA UDI 3abb1fc8-a86b-4328-9d2d-62de7b6b3174 35 fields · synced May 30, 2026