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Midmark

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
Midmark FDA UDI
Generic Name
Ink printer FDA UDI
Device Name
Records and prints sterilization cycle data including time, chamber temperature, and pressure FDA UDI
Model / Reference
9A599001 FDA UDI
Description
Records and prints sterilization cycle data including time, chamber temperature, and pressure FDA UDI

Identifiers

Catalog Number
9A599001 FDA UDI
Primary DI / UDI-DI
00841709100314 FDA UDI
510(k) Number
K163337 FDA UDI
FDA Product Code
FLE FDA UDI
GMDN Term
Ink printer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6880 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Category: Ink printer

Midmark by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ink printer.

Cleared under the same submission

K163337 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Midmark Corporation

Sources (1)

  • FDA UDI 37bba2ce-f9e2-45df-a142-7d32b507e304 36 fields · synced Jun 8, 2026