FDA UDI
In Commercial Distribution
🇺🇸 United States
Haier
DI: 06949573548516
·
Model: HYC-639
·
Qingdao Haier Biomedical Co Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Haier
- Primary DI
- 06949573548516
- Version / Model
- HYC-639
- Catalog Number
- HYC-639
- Company Name
- Qingdao Haier Biomedical Co Ltd
- Labeler DUNS
- 529121599
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-12
- Public Version
- 1
- Public Version Date
- 2023-04-20
- Public Version Status
- New
- Public Device Record Key
- 74dab13e-fba7-40f1-b57e-6f8f2891b005
Device Description
Pharmaceutical Refrigerator
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 |
|---|---|---|---|---|
| JRM | Freezer | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17156 | Pharmacy refrigerator | A mains electricity (AC-powered) refrigerator specially designed for cool storage of pharmaceuticals, e.g., medications or live virus vaccines. It may be provided with a built-in alarm system that warns against unexpected temperature variations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06949573548516 | GS1 |