FDA UDI
In Commercial Distribution
🇺🇸 United States
DG Clean
DI: 08436583730799
·
Model: 213797
·
DIAGNOSTIC GRIFOLS SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DG Clean
- Primary DI
- 08436583730799
- Version / Model
- 213797
- Catalog Number
- 213797
- Company Name
- DIAGNOSTIC GRIFOLS SA
- Labeler DUNS
- 463625602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-21
- Public Version
- 2
- Public Version Date
- 2025-04-22
- Public Version Status
- Update
- Public Device Record Key
- 46116045-c00b-41e0-948f-3f5a6237b73a
Device Description
DG Clean is a solution for cleaning the probes of Grifols analyzers.
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JCB | Detergent | Pathology | 864.4010 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 08436583730782 | GS1 | 9 | In Commercial Distribution | ||
| Primary | 08436583730799 | GS1 |
Customer Contacts
- Phone
- (800) 452-6877
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius