| Primary Device ID | 00748426140466 |
| NIH Device Record Key | 5ea09d6e-131c-4b94-9448-a492a9ed9461 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medline-Microtek |
| Version Model Number | Surgical Slush - Hush-Slush Drape |
| Catalog Number | ORS-330N |
| Company DUNS | 106908437 |
| Company Name | Microtek Medical LLC |
| Device Count | 24 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00748426140466 [Unit of Use] |
| GS1 | 10748426140463 [Primary] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
[00748426140466]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-16 |
| Device Publish Date | 2025-04-08 |
| 00748426141128 | KNEE AND BODY STRAP, DISPOSABLE, NONWOVEN, TWO PIECE, 4" X 60" |
| 00748426140503 | Scope Pillow™ Warmer Drape, For use with ORS-2057 Series Fluid Warming System, 112 cm x 168 cm |
| 00748426140466 | Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 112 cm x 168 cm (44 i |
| 00748426140442 | Slush + Warmer Disc-Drape™, For use with ORS-1075HS Hush-Slush™ System, 132 cm x 168 cm (52 |
| 00748426140435 | Slush + Warmer Disc-Drape™, For use with ORS-1075HS Hush-Slush™ System, 112 cm x 168 cm (44 |
| 00748426140428 | Warmer Drape, For use with ORS-2000 Series Fluid Warming System, 132 cm x 168 cm (52 in x 66 in) |
| 00748426140411 | Warmer Drape, For use with ORS-2000 Series Fluid Warming System, 112 cm x 168 cm (44 in x 66 in) |
| 00748426140404 | Warmer Drape with Skirt, For use with ORS-2000 Series Fluid Warming System, 112 cm x 112 cm x 91 |
| 00748426140381 | Warmer Drape, For use with ORS-2000 Series Fluid Warming System, 112 cm x 112 cm (44 in x 44 in) |
| 00748426140374 | Microtek Warmer Drape, For use with Microtek E Series and ORS-2000 Series Fluid Warming Systems, |
| 00748426140350 | Microtek Warmer Drape, For use with Microtek E Series and ORS-2000 Series Fluid Warming Systems, |
| 00748426140336 | Microtek Hush-Slush™ 2.0 Slush + Warmer Disc-Drape, 112 cm x 168 cm (44 in x 66 in) |
| 00748426140312 | Microtek Slush + Warmer Disc-Drape™, 112 cm x 168 cm (44 in x 66 in) |
| 10748426140494 | Scope Cradle™, For Use with O.R. Solutions Warming Systems |
| 10748426140487 | Scope Pillow™ Warmer Drape, For use with ORS-2057 Series Fluid Warming System, 112 cm x 168 cm |
| 10748426140470 | Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 132 cm x 168 cm (52 i |
| 10748426140456 | Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 112 cm x 168 cm (44 i |
| 10748426140395 | Warmer Drape with Skirt, For use with ORS-2000 Series Fluid Warming System, 112 cm x 112 cm x 91 |
| 10748426140364 | Microtek Warmer Drape, For use with Microtek E Series and ORS-2000 Series Fluid Warming Systems, |
| 10748426140340 | Microtek Warmer Drape, For use with Microtek E Series and ORS-2000 Series Fluid Warming Systems, |
| 10748426140326 | Hush-Slush™ 2.0 Slush + Warmer Disc-Drape, For use with the Hush-Slush™ 2.0 (ESW7L) and Hush |
| 00748426141104 | Hush Slush Surgical Slush Machine |
| 00748426140756 | Irrigation Solution Warmer, 9.4 Liter |
| 00748426140749 | Irrigation Solution Warmer, 7.5 Liter |
| 00748426140732 | Irrigation Solution Warmer, 6.6 Liter |
| 00748426140725 | Irrigation Solution Warmer, 5.7 Liter |
| 00748426140718 | Irrigation Solution Warmer, 3.8 Liter |
| 00748426140695 | Hush Slush Surgical Slush Machine |