FDA UDI
In Commercial Distribution
🇺🇸 United States
ACE
DI: 00857969006655
·
Model: SA1028
·
ALFA WASSERMANN, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACE
- Primary DI
- 00857969006655
- Version / Model
- SA1028
- Catalog Number
- SA1028
- Company Name
- ALFA WASSERMANN, INC.
- Labeler DUNS
- 781990924
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-09
- Public Version
- 1
- Public Version Date
- 2020-04-17
- Public Version Status
- New
- Public Device Record Key
- aaa92abe-6fc1-411e-915b-1a5544ccc242
Device Description
ISE CLEANING AND SODIUM ELECTRODE CONDITIONER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59058 | Wash/cleaning solution IVD, automated/semi-automated system | A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857969006655 | GS1 |
Customer Contacts
- Phone
- 973-852-0178
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 26 Degrees Celsius