AccessGUDID - DEVICE: Fecal Extraction Device (08426950846833)

GUDID

Device Identifier (DI) Information

Brand Name: Fecal Extraction Device
Version or Model: 504837
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08426950846833
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: -100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62675	Calprotectin IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of calprotectin protein in a clinical specimen, using a chemiluminescent immunoassay method. This test is commonly used to aid in the diagnosis of inflammatory bowel disease or other causes of intestinal inflammation.	Active	false
52862	Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens or markers associated with gastrointestinal disease in a clinical specimen, using an enzyme immunoassay (EIA) method. Markers to be assayed may include pepsinogen I, pepsinogen II, gastrin and/or antibodies to the bacteria Helicobacter pylori.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXO	Calprotectin, Fecal

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c7c3833-a787-40b6-893d-29f8acfbed1b
Public Version Date: October 16, 2023
Public Version Number: 5
DI Record Publish Date: November 30, 2018