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Flexicare

FDA UDI

Class I (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
Flexicare FDA UDI
Generic Name
Straight/elbow breathing circuit connector, single-use FDA UDI
Device Name
Bi-PAP Connector 22m-15F/22m with Exhaust Valve and Pressure Line FDA UDI
Model / Reference
010-608U FDA UDI
Description
Bi-PAP Connector 22m-15F/22m with Exhaust Valve and Pressure Line FDA UDI

Identifiers

Primary DI / UDI-DI
05055788706373 FDA UDI
FDA Product Code
BZA FDA UDI
GMDN Term
Straight/elbow breathing circuit connector, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5810 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

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: Straight/elbow breathing circuit connector, single-use

Flexicare by Flexicare Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Straight/elbow breathing circuit connector, 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 508820e1-540e-4215-91a1-0f6293547722 33 fields · synced May 31, 2026