FDA UDI
In Commercial Distribution
🇺🇸 United States
Skytron warming cabinet
DI: 10841736111953
·
Model: W2-653027
·
SKYTRON LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Skytron warming cabinet
- Primary DI
- 10841736111953
- Version / Model
- W2-653027
- Company Name
- SKYTRON LLC
- Labeler DUNS
- 078375583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 1
- Public Version Date
- 2020-05-08
- Public Version Status
- New
- Public Device Record Key
- 536b2dc6-b86e-4c71-a19c-d8fa20898802
Device Description
Warming cabinet, 2 compartment, 3 adjustable shelves, digital controls with lockout and USB data ret
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | 880.5725 | 2 |
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 |
|---|---|---|---|---|---|---|
| Primary | 10841736111953 | GS1 |
Customer Contacts
- Phone
- 800-759-8766
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 14 – 31.3 Millimeter of Mercury
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- -40 – 159 Degrees Fahrenheit