Identity
- Trade Name
- Cadwell FDA UDI
- Generic Name
- Home-use sleep apnoea recording system FDA UDI
- Device Name
- Velstretch Band Infant 1in Loop FDA UDI
- Model / Reference
- 302523-200-0100 FDA UDI
- Description
- Velstretch Band Infant 1in Loop FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067103654 FDA UDI
- 510(k) Number
- K903300 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Home-use sleep apnoea recording system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 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
Yes
FDA UDI
Category: PolysomnographHome-use sleep apnoea recording system
Cadwell by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K903300 also covers:
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- SleepmateDisposable RIP Bands — Ambu A/S
- SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice — Ambu A/S
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- SleepmatePiezo Crystal Sensor & Band, Infant/Ped, Velcro Tab — Ambu A/S
- SleepmateRIPmate A5 Abdomen Processor — Ambu A/S
- SleepmateRIPmate Abdomen Processor — Ambu A/S
- SleepmateRIPmate Belt - Adult 1-1/2" Band (26-65") — Ambu A/S
- SleepmateRIPmate Belt - Pediatric 1-1/2" Band (14-48") — Ambu A/S
- SleepmateRIPmate Cable - 50 cm — Ambu A/S
- SleepmateRIPmate Inductance Kit - Alice 5 — Ambu A/S
- SleepmateRIPmate Kit - Integrated RIP Keyhole — Ambu A/S
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
- Cadwell Industries, Inc.
Sources (1)
- FDA UDI bebd6926-5893-4b92-b153-ab98ad20d9e5 35 fields · synced Jun 9, 2026