Adult Circ Sing Lmb HTD/W (22mm SmthB Tube) & AutoFCh w/PrLn

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name: Adult Circ Sing Lmb HTD/W (22mm SmthB Tube) & AutoFCh w/PrLn FDA UDI
Generic Name: Ventilator breathing circuit, single-use FDA UDI
Model / Reference: 038-35-964U FDA UDI

Identifiers

Primary DI / UDI-DI: 05055788709657 FDA UDI
FDA Product Code: BTT FDA UDI
BZE FDA UDI
GMDN Term: Ventilator breathing circuit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5450 FDA UDI
868.5270 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ventilator breathing circuit, single-use Heated respiratory humidifier

Adult Circ Sing Lmb HTD/W (22mm SmthB Tube) & AutoFCh w/PrLn by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Heated respiratory humidifier.

Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
A Series Heated Humidifier — Respironics, Inc. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Flexicare Medical Limited

Sources (1)

FDA UDI f9a90aff-c4f6-47e6-bde8-f3ce634b2479 32 fields · synced May 30, 2026