Headstar

FDA UDI

Class I (US FDA UDI)

by Headstar Medical Products Co., Ltd.

Identity

Trade Name: HEADSTAR FDA UDI
Generic Name: Airway pressure monitor, non-powered FDA UDI
Device Name: REUSABLEDIVERTER, AUTOCLAVED TO 121 Degree C ( MATERIAL : PC ) Package: 250 PCS per PE BAG, 250 PCS in a CS FDA UDI
Model / Reference: HS-9212 FDA UDI
Description: REUSABLEDIVERTER, AUTOCLAVED TO 121 Degree C ( MATERIAL : PC ) Package: 250 PCS per PE BAG, 250 PCS in a CS FDA UDI

Identifiers

Primary DI / UDI-DI: 04711402236077 FDA UDI
FDA Product Code: CAE FDA UDI
GMDN Term: Airway pressure monitor, non-powered FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Airway pressure monitor, non-powered

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

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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 I	Pending data

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Manufacturer

Manufacturer: Headstar Medical Products Co., Ltd.

Sources (1)

FDA UDI 857adc16-3c75-4e8f-b7b8-9dd3acda6fee 33 fields · synced May 30, 2026