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Sleepmate / SparepartBody Position Band
FDA UDIClass II (US FDA UDI)
by Ambu A/S
Identity
- Trade Name
- Sleepmate / SparepartBody Position Band FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Body Position Band FDA UDI
- Model / Reference
- 815000-000 FDA UDI
- Description
- Body Position Band FDA UDI
Identifiers
- Catalog Number
- 815000-000 FDA UDI
- Primary DI / UDI-DI
- 05707480042548 FDA UDI
- 510(k) Number
- K923033 FDA UDI
- FDA Product Code
- LXJ FDA UDI
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polysomnograph
Sleepmate / SparepartBody Position Band by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Natus — Embla Systems · Class II
Cleared under the same submission
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
- Ambu A/S
Sources (1)
- FDA UDI 112611b8-38bb-4fc7-9b02-a8b0628bcb7a 36 fields · synced May 31, 2026