FDA UDI
In Commercial Distribution
🇺🇸 United States
HYDRASYS WASH SOLUTION (10)
DI: 03607360045411
·
Model: 4541
·
SEBIA
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYDRASYS WASH SOLUTION (10)
- Primary DI
- 03607360045411
- Version / Model
- 4541
- Catalog Number
- 4541
- Company Name
- SEBIA
- Labeler DUNS
- 276801933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-16
- Public Version
- 1
- Public Version Date
- 2022-12-26
- Public Version Status
- New
- Public Device Record Key
- 586e87d1-c139-413a-ba25-ede486bffa1a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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
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 | 03607360045411 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT FREEZE FRAGILE HANDLE WITH CARE PROTECT FROM HEAT THIS WAY UP