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Iradimed

FDA UDI

Class II (US FDA UDI)

by Iradimed Corporation

Identity

Trade Name
Iradimed FDA UDI
Generic Name
Straight/elbow breathing circuit connector, single-use FDA UDI
Device Name
Adaptor, Anesthesia Airway FDA UDI
Model / Reference
1845-25 FDA UDI
Description
Adaptor, Anesthesia Airway FDA UDI

Identifiers

Catalog Number
1845-25 FDA UDI
Primary DI / UDI-DI
00856038001706 FDA UDI
510(k) Number
K172200 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Straight/elbow breathing circuit connector, single-use 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Straight/elbow breathing circuit connector, single-use

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

Similar devices

Also classified as Straight/elbow breathing circuit connector, single-use.

Cleared under the same submission

K172200 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Iradimed Corporation

Sources (1)

  • FDA UDI 54807b44-9a57-4a45-8f7d-880f0036ea9e 35 fields · synced Jun 8, 2026