FDA UDI
In Commercial Distribution
🇺🇸 United States
Steelco
DI: 08051520005305
·
Model: AD 400/1
·
STEELCO SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Steelco
- Primary DI
- 08051520005305
- Version / Model
- AD 400/1
- Catalog Number
- AD 400/1
- Company Name
- STEELCO SPA
- Labeler DUNS
- 428717469
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-29
- Public Version
- 1
- Public Version Date
- 2022-12-07
- Public Version Status
- New
- Public Device Record Key
- 77555553-40b2-4c75-9f59-94fc62629486
Device Description
This device drying cabinet provides fast drying of instruments, equipment and general items. It has dedicated connections allowing forced drying of anesthetic instruments.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| JRJ | Unit, Drying | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17449 | Breathing circuit dryer, closed | An electrically-powered cabinet designed to dry the interior of breathing circuit equipment (e.g., hoses, bags, masks) after washing, to prevent bacterial growth and equipment deterioration. The cabinet is designed to operate with closed doors, but may operate with open doors. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08051520005305 | GS1 |