AccessGUDID - DEVICE: CARDINAL HEALTH (20885380020282)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: B1077-25
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B1077-25
Company Name: Cardinal Health 200, LLC

Primary DI Number: 20885380020282
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2021
Device Count: 30
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: H.pylori Rapid Test

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):	No
Over the Counter (OTC):	Yes
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?
62029	Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test	A collection of reagents and other associated materials intended to be used for the qualitative detection of immunoglobulin G (IgG) antibodies to Helicobacter pylori in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses, and is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment. Infection with H. pylori is associated with gastroduodenal disorders such as active chronic gastritis, gastric, and duodenal ulcers.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LYR	Helicobacter pylori

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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22a42c46-4d14-45e7-b384-d420cc8609bd
Public Version Date: September 01, 2021
Public Version Number: 6
DI Record Publish Date: September 01, 2016