FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline-Microtek
DI: 00748426140497
·
Model: Fluid Warming - Warmer Equipment
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Medline-Microtek
- Primary DI
- 00748426140497
- Version / Model
- Fluid Warming - Warmer Equipment
- Catalog Number
- ORS-6000
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-08
- Public Version
- 1
- Public Version Date
- 2025-04-16
- Public Version Status
- New
- Public Device Record Key
- 9f419ded-8bc6-4a16-9d60-10d1099267b6
Device Description
Scope Cradle™, For Use with O.R. Solutions Warming Systems
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 33512 | Multi-purpose warming cabinet, mobile | A mains electricity (AC-powered) mobile device designed to warm various items and products prior to use, e.g., bags of irrigation or intravenous (IV) solutions, blankets or clothing to cover or put onto a patient, or clothing for the operating room (OR) personnel to adorn. It typically consists of a heat insulated enclosure with a sealing door, shelves, heating element(s), a thermostat and operating controls. This is a freestanding cabinet equipped with wheels that is designed to be wheeled (moved) from one location to another within a building complex. It may also be used in a laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10748426140494 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00748426140497 | GS1 |