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Neonatal Single Limb Heated Wire Breathing System HFOT 1.6 Kit 1

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
Neonatal Single Limb Heated Wire Breathing System HFOT 1.6 Kit 1 FDA UDI
Generic Name
Ventilator breathing circuit, single-use FDA UDI
Model / Reference
038-33-402U FDA UDI

Identifiers

Primary DI / UDI-DI
05055788771081 FDA UDI
FDA Product Code
BZE FDA UDI
BTT FDA UDI
GMDN Term
Ventilator breathing circuit, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

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: Ventilator breathing circuit, single-use

Neonatal Single Limb Heated Wire Breathing System HFOT 1.6 Kit 1 by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Ventilator breathing circuit, 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 18f88e6b-7dcd-453e-9f76-b5f4758cd78f 32 fields · synced May 30, 2026