Identity
- Trade Name
- SLEEP SYSTEM NITETIME FDA UDI
- Generic Name
- Assistive sleeping cushion set FDA UDI
- Device Name
- SLEEP SYSTEM NITETIME FDA UDI
- Model / Reference
- LEG WRAPS MEDIUM FDA UDI
- Description
- SLEEP SYSTEM NITETIME FDA UDI
Identifiers
- Catalog Number
- SA5531US FDA UDI
- Primary DI / UDI-DI
- 05050962293717 FDA UDI
- FDA Product Code
- FNJ FDA UDI
- GMDN Term
- Assistive sleeping cushion set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5120 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assistive sleeping cushion set
Sleep System Nitetime by The Helping Hand Company (ledbury) Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive sleeping cushion set.
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- Ever-Soft Positioning Wedge — Dynarex Corp. · Class I
- SLEEP SYSTEM NITETIME — THE HELPING HAND COMPANY (LEDBURY) LIMITED · Class I
- SLEEP SYSTEM NITETIME — THE HELPING HAND COMPANY (LEDBURY) LIMITED · Class I
- SLEEP SYSTEM NITETIME — THE HELPING HAND COMPANY (LEDBURY) LIMITED · Class I
- SLEEP SYSTEM NITETIME — THE HELPING HAND COMPANY (LEDBURY) LIMITED · Class I
- SLEEP SYSTEM NITETIME — THE HELPING HAND COMPANY (LEDBURY) LIMITED · Class I
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
- The Helping Hand Company (ledbury) Limited
Sources (1)
- FDA UDI 3b0a0ed5-9eb3-440c-91f2-9f3eec31b52e 35 fields · synced May 30, 2026