BioSentry®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: BioSentry® FDA UDI
Generic Name: Lung biopsy procedure kit FDA UDI
Model / Reference: A FDA UDI

Identifiers

Catalog Number: H787768022019S1 FDA UDI
Primary DI / UDI-DI: 00884450808122 FDA UDI
FDA Product Code: OMT FDA UDI
GMDN Term: Lung biopsy procedure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4755 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Lung biopsy procedure kit

BioSentry® by Merit Medical Systems, 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: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 710e6932-423e-4d27-b384-7791d9b7930c 33 fields · synced Jun 9, 2026