AccessGUDID - DEVICE: Healgen (00816490021131)

GUDID

Device Identifier (DI) Information

Brand Name: Healgen
Version or Model: GAHCG-103a
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GAHCG-103a
Company Name: Healgen Scientific Limited Liability Company

Primary DI Number: 00816490021131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031802328 *Terms of Use

Device Description: hCG women pregnancy Test midstream (Urine; 25mIU/ml)

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:	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?
54216	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter

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
Handling Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7069a62-a06f-438c-91c0-32d69c3de9be
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 31, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20816490021135	50	10816490021138	In Commercial Distribution	Case
10816490021138	20	00816490021131	In Commercial Distribution	Inner Pack
40816490021139	80	30816490021132	In Commercial Distribution	Case
30816490021132	20	00816490021131	In Commercial Distribution	Inner Pack