Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: MEDLINE FDA UDI
Generic Name: Endoscopic bite block, basic, single-use FDA UDI
Device Name: BLOCK,BITE,144/CS FDA UDI
Model / Reference: MDS0964000 FDA UDI
Description: BLOCK,BITE,144/CS FDA UDI

Identifiers

Catalog Number: MDS0964000 FDA UDI
Primary DI / UDI-DI: 10884389151150 FDA UDI
FDA Product Code: MNK FDA UDI
GMDN Term: Endoscopic bite block, basic, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1500 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscopic bite block, basic, single-use

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

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Also classified as Endoscopic bite block, basic, single-use.

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E-Z Guard — US Endoscopy · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Breathe-EZ — Micro-tech Usa · Class I
Breathe-EZ — Micro-tech Usa · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Medline Industries, Inc.

Sources (1)

FDA UDI e52539ac-77cf-413a-888e-b0747715bcbe 35 fields · synced Jun 6, 2026