Identity
- Trade Name
- RESUSCITATION KIT FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Sunset Pediatric Resuscitation Kit, T/S Masks, Manometer, PEEP and Bacterial Filter This kit contains: 1 RES8110H, 1 SBC01S, 1SBC01T, 1 BF2200, 1 RES8205B, 1 RES8201L FDA UDI
- Model / Reference
- RES8400 FDA UDI
- Description
- Sunset Pediatric Resuscitation Kit, T/S Masks, Manometer, PEEP and Bacterial Filter This kit contains: 1 RES8110H, 1 SBC01S, 1SBC01T, 1 BF2200, 1 RES8205B, 1 RES8201L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530105044 FDA UDI
- FDA Product Code
- CAE FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary resuscitator, manual, single-use
Resuscitation Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
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- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
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
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 66ed8492-f3b4-4918-a4ff-8236e12addd3 34 fields · synced May 31, 2026