Identity
- Trade Name
- HEADSTAR FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, reusable FDA UDI
- Device Name
- SILICONE RESUSCITATOR BAG ADULT With POP OFF (With HS Logo) AUTOCLAVE TO 121 Degree C MATERIAL : PC ONE PC PER BAG, TEN PC PER CTN With INSTRUCTION BOOKLET FDA UDI
- Model / Reference
- HS-9288AP FDA UDI
- Description
- SILICONE RESUSCITATOR BAG ADULT With POP OFF (With HS Logo) AUTOCLAVE TO 121 Degree C MATERIAL : PC ONE PC PER BAG, TEN PC PER CTN With INSTRUCTION BOOKLET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711402230280 FDA UDI
- 510(k) Number
- K002846 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Pulmonary resuscitator, manual, reusable
Headstar by Headstar Medical Products Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, reusable.
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- MedSource Resuscitator, Infant (BVM), 10/case — MEDSOURCE INTERNATIONAL LLC · Class II
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Cleared under the same submission
K002846 also covers:
- HEADSTAR — Headstar Medical Products Co., Ltd.
- HEADSTAR — Headstar Medical Products Co., Ltd.
- HEADSTAR — Headstar Medical Products Co., Ltd.
- MedSource Disposable Resuscitator, Adult (10/cs) — MEDSOURCE INTERNATIONAL LLC
- MedSource Disposable Resuscitator, Infant (10/cs) — MEDSOURCE INTERNATIONAL LLC
- MedSource Disposable Resuscitator, Pediatric (10/cs) — MEDSOURCE INTERNATIONAL LLC
- MedSource Resuscitator, Adult (BVM), 10/case — MEDSOURCE INTERNATIONAL LLC
- MedSource Resuscitator, Infant (BVM), 10/case — MEDSOURCE INTERNATIONAL LLC
- MedSource Resuscitator, Pediatric (BVM), 10/case — MEDSOURCE INTERNATIONAL LLC
- PremierPro — SVS LLC
- PremierPro — SVS LLC
- PremierPro — SVS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Headstar Medical Products Co., Ltd.
Sources (1)
- FDA UDI a395b6e5-c5fa-4919-a4ab-5523c926bbc9 34 fields · synced May 31, 2026