← Back to catalogue

HME-Booster T-Piece

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
HME-Booster T-Piece FDA UDI
Generic Name
Straight/elbow breathing circuit connector, single-use FDA UDI
Model / Reference
360-000-000U FDA UDI

Identifiers

Primary DI / UDI-DI
05055788792277 FDA UDI
FDA Product Code
BTT FDA UDI
GMDN Term
Straight/elbow breathing circuit connector, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5450 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

No

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: Straight/elbow breathing circuit connector, single-use

HME-Booster T-Piece by Flexicare Medical Limited — Class II — 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

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

Manufacturer

Manufacturer
Flexicare Medical Limited

Sources (1)

  • FDA UDI 107f2a7c-f60e-4ad5-8276-c6522b9391a7 32 fields · synced May 30, 2026