AccessGUDID - DEVICE: Crit-Line® (00840861101139)

GUDID

Device Identifier (DI) Information

Brand Name: Crit-Line®
Version or Model: CL10041001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fresenius Medical Care Holdings, Inc.

Primary DI Number: 00840861101139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 958291411 *Terms of Use

Device Description: Crit-Line in a Clip

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":	No
For Single-Use:	No
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?
37218	Haemodialysis system blood volume monitor	A mains electricity (AC-powered) device designed to non-invasively monitor the relative variations of the blood volume during a haemodialysis treatment. The blood is lead through a chamber in this device where measurements are taken and calculations of haematocrit (volume percent of erythrocytes), haemoglobin oxygen saturation (SpO2), and percent change in blood volume are made and displayed. In addition the monitor may estimate and display the urea reduction ration (URR) on relative changes in urea nitrogen concentration in the spent dialysate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOC	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 125 Degrees Celsius
Storage Environment Temperature: between -40 and 257 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d7329c8-ba00-4629-9363-c561bd623eaa
Public Version Date: July 17, 2024
Public Version Number: 3
DI Record Publish Date: November 17, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(801)451-9000
Email: xxx@xxx.xxx

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