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Headstar

FDA UDI

Class I (US FDA UDI)

by Headstar Medical Products Co., Ltd.

Identity

Trade Name
HEADSTAR FDA UDI
Generic Name
Venturi oxygen face mask FDA UDI
Device Name
VENTURI MASK KIT - CHILD CHILD NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT) Package: 50 PCS in CS FDA UDI
Model / Reference
HP-8609 FDA UDI
Description
VENTURI MASK KIT - CHILD CHILD NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT) Package: 50 PCS in CS FDA UDI

Identifiers

Primary DI / UDI-DI
04711402233021 FDA UDI
FDA Product Code
BYF FDA UDI
GMDN Term
Venturi oxygen face mask FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5600 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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Venturi oxygen face mask

Headstar by Headstar Medical Products Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Venturi oxygen face mask.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Headstar Medical Products Co., Ltd.

Sources (1)

  • FDA UDI 54e8f74b-85c7-4ba5-8234-1545da8e9405 33 fields · synced May 30, 2026