FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline-Microtek
DI: 00748426140695
·
Model: Surgical Slush - Hush-Slush Equipment
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medline-Microtek
- Primary DI
- 00748426140695
- Version / Model
- Surgical Slush - Hush-Slush Equipment
- Catalog Number
- ORS-1075HS
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-18
- Public Version
- 2
- Public Version Date
- 2025-10-14
- Public Version Status
- Update
- Public Device Record Key
- c03a6479-5f5c-46c0-bfbc-8bf713707c50
Device Description
Hush Slush Surgical Slush Machine
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHC | Warmer, Irrigation Solution | Physical Medicine | 890.5950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36756 | Ice maker/dispenser | A mains electricity (AC-powered) device with the freezing capabilities to transform water from a liquid to a solid mass, producing non-contaminated ice. It will typically have a storage chamber that facilities automatic dispensing of the ice from a storage chamber when needed, or for manual collection. The ice produced can be used for a variety of purposes in healthcare settings, e.g., cooling and/or temporary preservation of blood, organs, tissues, in physiotherapy (used in ice bags or baths) or for cooling soft drinks. The storage bin can be either closed or open and the ice produced can be supplied as flakes, crushed, cubes or in other forms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00748426140695 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal