Curaplex BT-42610
Curaplex BT-42610 (3271-61002) is a basic bed sheet (FDA Class I; FDA product code KME, Bedding, Disposable, Medical) made by Bound Tree Medical, LLC, listed in FDA GUDID since 30 Dec 2022 (UDI-DI 00810071633324), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810071633324 | Date30 Dec 2022 | StatusListed |
Official records
- AccessGUDID record 00810071633324
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Curaplex
- Generic name
- Basic bed sheet, single-use
- Model / Ref / Catalog
- BT-42610, 3271-61002
- Primary DI / UDI-DI
- 00810071633324
- FDA product code
- KME
- GMDN term
- Basic bed sheet, single-use
- Device class
- Class I
- Regulation number
- 880.6060
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KME (BEDDING, DISPOSABLE, MEDICAL).
- PILLOWS- SINGLE PATIENT USE by Abco Dealers, Inc.
- PILLOW COVER, ANTI-MICROBIAL by American Threshold Industries, Inc.
- DRY COMFORT DISPOSABLE UNDERPAD by Health Tec, Inc.
- PLASTIC DISPOSABLE BIB by Fred Sammons, Inc.
- INFANT SCALE DISPOSABLE LINER by Hydro-Med Products, Inc.
- TERRYCLOTH BIBS by Fred Sammons, Inc.
- PAD, BED LINEN PROTECTIVE by Quality Disposables, Inc.
- DEPEND UNDERPAD by KIMBERLY-CLARK CORPORATION
- TOWELS, SHEETS, PILLOWCASES by Abco Dealers, Inc.
- PILLOW, CARTER ARM ELEVATION by Depuy, Inc.