FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00085412081908
·
Model: 4B7870X
·
BAXTER HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00085412081908
- Version / Model
- 4B7870X
- Catalog Number
- 4B7870X
- Company Name
- BAXTER HEALTHCARE CORPORATION
- Labeler DUNS
- 005083209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2025-06-26
- Public Version Status
- Update
- Public Device Record Key
- 72adfde1-4d9c-4baa-9bd4-321e0c1e22a1
Device Description
1.6% Sodium Chloride Processing Solution, 1000 mL
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSW | SYSTEM, PROCESSING FOR FROZEN BLOOD | Hematology | 864.9145 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45519 | Blood cell freeze/thaw system | An assembly of devices designed for the automated processing of red blood cells received indirectly from a donor so that the cells can be safely frozen for storage in a closed, disposable set, and when needed, thawed for use. The assembly will typically add an appropriate substance (e.g., glycerol) to the blood cells to allow freezing, and facilitate the thawing process. The assembly may also wash the red blood cells to remove glycerol and plasma and extracellular components; it may also resuspend the cells in an additive solution. It will typically be comprised of pumps, a centrifuge, air detectors, a dedicated shaker, monitoring devices, disposable set, and possibly print-out facilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60085412081900 | GS1 | CASE | 14 | In Commercial Distribution | |
| Primary | 00085412081908 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Recommended Storage - Room Temperature (25 Degrees Celsius). Avoid excessive heat. Protect from freezing.