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Smoothbore Catheter Mount 15mm Swivel Elbow with Double Port Cap and Seal 22F an

FDA UDI

Class I (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
Smoothbore Catheter Mount 15mm Swivel Elbow with Double Port Cap and Seal 22F an FDA UDI
Generic Name
Breathing circuit catheter mount, single-use FDA UDI
Model / Reference
038-61-326U FDA UDI

Identifiers

Primary DI / UDI-DI
05055788768623 FDA UDI
FDA Product Code
CAI FDA UDI
GMDN Term
Breathing circuit catheter mount, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5240 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Breathing circuit catheter mount, single-use

Smoothbore Catheter Mount 15mm Swivel Elbow with Double Port Cap and Seal 22F an by Flexicare Medical Limited — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Breathing circuit catheter mount, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flexicare Medical Limited

Sources (1)

  • FDA UDI db9a0459-dcd0-40cd-879f-52a95a2301dc 32 fields · synced Jun 8, 2026