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IMed Products

FDA UDI

Class U (US FDA UDI)

by Integrated Medical Systems, Inc.

Identity

Trade Name
IMed Products FDA UDI
Generic Name
Percutaneous catheter protector, professional FDA UDI
Device Name
IMedGuard 1"/4mm Disc w/CHG, 10/Bx FDA UDI
Model / Reference
IM36026 FDA UDI
Description
IMedGuard 1"/4mm Disc w/CHG, 10/Bx FDA UDI

Identifiers

Catalog Number
IM36026 FDA UDI
Primary DI / UDI-DI
10853155008684 FDA UDI
510(k) Number
K200641 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Percutaneous catheter protector, professional FDA UDI

Classification

Device Class
U 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: Percutaneous catheter protector, professional

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

Similar devices

Also classified as Percutaneous catheter protector, professional.

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 ee525364-1002-4ee0-b0dc-b702d25ae067 35 fields · synced May 29, 2026