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Vitek® Reveal™ Sealer

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® REVEAL™ SEALER FDA UDI
Generic Name
Package sealing unit FDA UDI
Device Name
The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate. FDA UDI
Model / Reference
900-00003 FDA UDI
Description
The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate. FDA UDI

Identifiers

Primary DI / UDI-DI
00860007326912 FDA UDI
510(k) Number
K230675 FDA UDI
FDA Product Code
SAN FDA UDI
GMDN Term
Package sealing unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Package sealing unit

Vitek® Reveal™ Sealer by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Package sealing unit.

Cleared under the same submission

K230675 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 9d11471a-f920-4dc7-946d-19f5713341c8 34 fields · synced Jun 1, 2026