FDA UDI
In Commercial Distribution
🇺🇸 United States
NxStage PureFlow-B Solution
DI: 00842289101265
·
Model: RFP-401-BB
·
NXSTAGE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NxStage PureFlow-B Solution
- Primary DI
- 00842289101265
- Version / Model
- RFP-401-BB
- Company Name
- NXSTAGE MEDICAL, INC.
- Labeler DUNS
- 088013219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b5937b9c-dbd9-4f9d-b5de-f2d68cb6251c
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61616 | Haemodialysis dialysate solution | A sterile, ready-to-use solution with an electrolyte composition similar to that of blood (i.e., a dialysate) intended to exchange solutes with blood across a semi-permeable membrane. It is used within a haemodialysis system to remove metabolic wastes from the blood and to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3-), acetate, citrate, lactate]. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10842289101262 | GS1 | Shipping Box | 2 | In Commercial Distribution | |
| Primary | 00842289101265 | GS1 |
Customer Contacts
- Phone
- 1-866-697-8243
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius