FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 00885380011743
·
Model: B4136-3A
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 00885380011743
- Version / Model
- B4136-3A
- Catalog Number
- B4136-3A
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-02
- Public Version
- 1
- Public Version Date
- 2021-09-10
- Public Version Status
- New
- Public Device Record Key
- 1392f19d-410c-4d48-b4b7-46420cf8ff4f
Device Description
Wright Stain Buffer pH 7.15, 4.4 g vial
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPM | General purpose reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42651 | Buffered isotonic saline reagent IVD | A buffered isotonic saline solution intended to be used alone or in combination with other IVDs in 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 | 20885380011747 | GS1 | PACK | 10 | In Commercial Distribution | |
| Primary | 00885380011743 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius