FDA UDI
In Commercial Distribution
🇺🇸 United States
Sodium Chloride 0.9% (Normal Saline), USP Sterile Grade
DI: B891Z13776
·
Model: 04
·
INTERMOUNTAIN LIFE SCIENCES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Sodium Chloride 0.9% (Normal Saline), USP Sterile Grade
- Primary DI
- B891Z13776
- Version / Model
- 04
- Catalog Number
- Z1377
- Company Name
- INTERMOUNTAIN LIFE SCIENCES, LLC
- Labeler DUNS
- 117437522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-08-14
- Public Version
- 1
- Public Version Date
- 2020-08-24
- Public Version Status
- New
- Public Device Record Key
- 324aaa32-3227-4849-a1e1-f05299d1aa98
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIP | Formulations, Balanced Salt Solutions | Hematology | 864.2875 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62068 | Ex vivo cell culture medium | A solution used for the ex-vivo culture of human-derived or non-human cells [e.g., T-lymphocytes, mesenchymal stem cells (MSCs), embryonic stem cells, induced pluripotent stem cells (iPSC)] or immortalised cell lines (e.g., HaCat, HeLa, HEK-293, cos-7, PC-12) intended for cell therapy applications. The solution contains a combination of nutrients, which may include amino acids, vitamins and organic salts that are vital for the growth and maintenance of the cell type/line. It is not intended for in vitro fertilization (IVF) or in vitro diagnostic applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B891Z13776 | HIBCC | ||||
| Unit of Use | B891Z13770 | HIBCC |
Customer Contacts
- Phone
- 8012828610
- [email protected]