Identity
- Trade Name
- Tom 2 Pediatric Pulse Mattress FDA UDI
- Generic Name
- Flotation therapy bed, neonatal FDA UDI
- Device Name
- Pediatric pulse mattress FDA UDI
- Model / Reference
- 7770-PPM-TOM2 FDA UDI
- Description
- Pediatric pulse mattress FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845699005864 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Flotation therapy bed, neonatal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5550 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Flotation therapy bed, neonatal
Tom 2 Pediatric Pulse Mattress by Sizewise Rentals, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flotation therapy bed, neonatal.
- Pediatric Pulse LAL Mattress — SIZEWISE RENTALS, L.L.C. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Sizewise Rentals, L.l.c.
Sources (1)
- FDA UDI 5c7961c2-fde9-4e08-83b9-27255055c6b3 34 fields · synced Jun 6, 2026