AccessGUDID - DEVICE: NXSTAGE CARTRIDGE EXPRESS (M535CAR1720)

GUDID

Device Identifier (DI) Information

Brand Name: NXSTAGE CARTRIDGE EXPRESS
Version or Model: CAR-172
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NXSTAGE MEDICAL, INC.

Primary DI Number: M535CAR1720
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?
61674	Haemodialysis/haemofiltration system component set	A collection of sterile devices, which includes a dialyser, intended to be integrated within a system for haemodialysis and haemofiltration to treat acute or chronic renal failure by removing toxins and/or replacing electrolytes in blood; it may also be used in the treatment of fluid overload (hypervolemia). In addition to the dialyser the set includes an array of tubing and connectors, and is intended to be connected to the system pump/monitor; it is intended to be used in the home and healthcare settings. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ebcf49b-088d-4d5b-97ef-e16914026fcc
Public Version Date: November 08, 2018
Public Version Number: 3
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
M535CAR1725	6	M535CAR1720		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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