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HME-Booster T-piece WFL Comfort + Hygrovent S HMEF

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
HME-Booster T-piece WFL Comfort + Hygrovent S HMEF FDA UDI
Generic Name
Heat/moisture exchanger/microbial filter, sterile FDA UDI
Model / Reference
362-021-010U FDA UDI

Identifiers

Primary DI / UDI-DI
05055788792352 FDA UDI
FDA Product Code
BTT FDA UDI
GMDN Term
Heat/moisture exchanger/microbial filter, sterile 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: Heat/moisture exchanger/microbial filter, sterile

HME-Booster T-piece WFL Comfort + Hygrovent S HMEF by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heat/moisture exchanger/microbial filter, sterile.

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 70485f93-6a42-4cc3-9d8f-6ce24c7d5aef 32 fields · synced May 31, 2026