AccessGUDID - DEVICE: NxStage PureFlow B Solution (M535RFP4010)

GUDID

Device Identifier (DI) Information

Brand Name: NxStage PureFlow B Solution
Version or Model: RFP-401
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NXSTAGE MEDICAL, INC.

Primary DI Number: M535RFP4010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 088013219 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a4b195a-7897-4ec3-8b3e-58b73495c54f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M535RFP4015	2	M535RFP4010		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-866-697-8243
Email: info@nxstage.com

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