AccessGUDID - DEVICE: Complete Circle Health (00860383000307)

GUDID

Device Identifier (DI) Information

Brand Name: Complete Circle Health
Version or Model: LMBCS20A99
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PWL SOLUTIONS LLC

Primary DI Number: 00860383000307
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2017
Device Count: 3
Labeler D-U-N-S® Number*: 080312287 *Terms of Use

Device Description: Home Midstream Pregnancy 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?
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
Storage Environment Temperature: between 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 6.0 Millimeter

Device Record Status

Public Device Record Key: 39b088b4-ad1d-4373-b9f7-7bccb27589c8
Public Version Date: January 20, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016