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MedDrain

FDA UDI

Class I (US FDA UDI)

by Armm Inc.

Identity

Trade Name
MedDrain FDA UDI
Generic Name
Sump drain FDA UDI
Device Name
MedDrain 8.5mm Double Sump Drain - 16 Small Eyes, 14" Long FDA UDI
Model / Reference
25297 FDA UDI
Description
MedDrain 8.5mm Double Sump Drain - 16 Small Eyes, 14" Long FDA UDI

Identifiers

Primary DI / UDI-DI
10850082007940 FDA UDI
510(k) Number
K931607 FDA UDI
FDA Product Code
GBN FDA UDI
GMDN Term
Sump drain FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Sump drain

MedDrain by Armm Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sump drain.

Cleared under the same submission

K931607 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Armm Inc.

Sources (1)

  • FDA UDI 42aa0491-c732-42cb-ac5b-66e7f7c3c3c8 35 fields · synced May 30, 2026