Identity
- Trade Name
- Xltek FDA UDI
- Generic Name
- Sleep disorder interpretive software FDA UDI
- Device Name
- Sandman Codec Software V.2.0 CD-Elite FDA UDI
- Model / Reference
- 4120082 FDA UDI
- Description
- Sandman Codec Software V.2.0 CD-Elite FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830023924 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Sleep disorder interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sleep disorder interpretive software
Xltek by Embla Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sleep disorder interpretive software.
- Polysmith Sleep System — NIHON KOHDEN AMERICA, INC. · Class II
- Polysmith Sleep System — NIHON KOHDEN AMERICA, INC. · Class II
- Polysmith Sleep System — NIHON KOHDEN AMERICA, INC. · Class II
- Embla — Embla Systems · Class II
- Xltek — Embla Systems · Class II
- Xltek — Embla Systems · Class II
- Xltek — Embla Systems · Class II
- Xltek — Embla Systems · 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
- Embla Systems
Sources (1)
- FDA UDI 599598a0-5a9b-428c-9d97-819a769168ec 33 fields · synced May 31, 2026