Identity
- Trade Name
- Blue Diamond FDA UDI
- Generic Name
- Operating table patient pressure distribution pad, reusable FDA UDI
- Device Name
- Blue Diamond® Flat Bottom Chest Roll. These viscoelastic polymer gel pads have a thin thermoformed skin and simulate human adipose tissue. They are a versatile roll used for axillary, shoulders, chest distensions, under knees, as well as bolster rolls to keep patients in place. A wide variety of shaped & sizes are available. This particular one is a smaller pediatric size FDA UDI
- Model / Reference
- BD2525 FDA UDI
- Description
- Blue Diamond® Flat Bottom Chest Roll. These viscoelastic polymer gel pads have a thin thermoformed skin and simulate human adipose tissue. They are a versatile roll used for axillary, shoulders, chest distensions, under knees, as well as bolster rolls to keep patients in place. A wide variety of shaped & sizes are available. This particular one is a smaller pediatric size FDA UDI
Identifiers
- Catalog Number
- BD2525 FDA UDI
- Primary DI / UDI-DI
- 15060797552030 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Operating table patient pressure distribution pad, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6450 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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Lot / Batch Number
No
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 4 Inch FDA UDILength — 3 Inch FDA UDIHeight — 3 Inch FDA UDI
Category: Operating table patient pressure distribution pad, reusable
Blue Diamond by David Scott Company. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- David Scott Company.
Sources (1)
- FDA UDI b94b8332-52ed-453d-b04d-3d921d17640b 36 fields · synced Jun 8, 2026