← Back to catalogue

Iradimed

FDA UDI

Class II (US FDA UDI)

by Iradimed Corporation

Identity

Trade Name
Iradimed FDA UDI
Generic Name
Electronic device storage cover, reusable FDA UDI
Device Name
Jacket, Disposable, POD FDA UDI
Model / Reference
1190-12 FDA UDI
Description
Jacket, Disposable, POD FDA UDI

Identifiers

Catalog Number
1190-12 FDA UDI
Primary DI / UDI-DI
00856038001829 FDA UDI
510(k) Number
K172200 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Electronic device storage cover, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electronic device storage cover, reusable

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

Similar devices

Also classified as Electronic device storage cover, reusable.

Cleared under the same submission

K172200 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Iradimed Corporation

Sources (1)

  • FDA UDI aedf6f45-0351-49ac-9356-1089c04366be 35 fields · synced Jun 8, 2026