Headstar

FDA UDI

Class II (US FDA UDI)

by Headstar Medical Products Co., Ltd.

Identity

Trade Name: HEADSTAR FDA UDI
Generic Name: Nebulizing system delivery set, single-use FDA UDI
Device Name: HP-2558 Nebulizer Kit (Adult) includes: nebulizer bottle x 1pc, nebulizer mask (adult) x 1pc, oxygen tube x 1pc. FDA UDI
Model / Reference: HP-2558 FDA UDI
Description: HP-2558 Nebulizer Kit (Adult) includes: nebulizer bottle x 1pc, nebulizer mask (adult) x 1pc, oxygen tube x 1pc. FDA UDI

Identifiers

Primary DI / UDI-DI: 04711402234226 FDA UDI
510(k) Number: K121770 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Nebulizing system delivery set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Nebulizing system delivery set, single-use

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

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Cleared under the same submission

K121770 also covers:

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

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Manufacturer

Manufacturer: Headstar Medical Products Co., Ltd.

Sources (1)

FDA UDI 000daa91-96c5-4b2c-8140-5d69b4ee7086 34 fields · synced Jun 8, 2026