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IMed Products

FDA UDI

Class II (US FDA UDI)

by Integrated Medical Systems, Inc.

Identity

Trade Name
IMed Products FDA UDI
Generic Name
Elastomeric infusion pump system FDA UDI
Device Name
IMed Elastomeric Pump - 270mL/2mL per Hour FDA UDI
Model / Reference
IM270002L FDA UDI
Description
IMed Elastomeric Pump - 270mL/2mL per Hour FDA UDI

Identifiers

Primary DI / UDI-DI
00810110920491 FDA UDI
510(k) Number
K151650 FDA UDI
FDA Product Code
MEB FDA UDI
GMDN Term
Elastomeric infusion pump system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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: Elastomeric infusion pump system

IMed Products by Integrated Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Elastomeric infusion pump system.

Cleared under the same submission

K151650 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integrated Medical Systems, Inc.

Sources (1)

  • FDA UDI 518b1879-32dc-45cf-b9d8-782e0946d0dc 34 fields · synced May 30, 2026