Identity
- Trade Name
- HEADSTAR FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- HP93111I-3U Infant PVC Resuscitator Kit, includes: HP-9333A PVC Manual Resuscitator Bag - Infant x 1 pc HP-8401C #1 Air Cushion Mask x 1 pc HP-3306B Single-patient-use Reservoir Valve set x 1 pc HP-1108 Oxygen Tubing x 1 pc *Package: PE bag/set* FDA UDI
- Model / Reference
- HP93111I-3U FDA UDI
- Description
- HP93111I-3U Infant PVC Resuscitator Kit, includes: HP-9333A PVC Manual Resuscitator Bag - Infant x 1 pc HP-8401C #1 Air Cushion Mask x 1 pc HP-3306B Single-patient-use Reservoir Valve set x 1 pc HP-1108 Oxygen Tubing x 1 pc *Package: PE bag/set* FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711402230488 FDA UDI
- 510(k) Number
- K002846 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use 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
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
Yes
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
MR Safe FDA UDI
Category: Pulmonary resuscitator, manual, single-use
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, single-use.
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- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- VT Sure — Pulmodyne Inc. · Class II
- SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
- Ventlab — Ventlab Corp. · Class I
- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
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 |
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Manufacturer
- Manufacturer
- Headstar Medical Products Co., Ltd.
Sources (1)
- FDA UDI 0dca0283-7e06-4322-9116-c565f06780e9 34 fields · synced May 30, 2026