BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Complete Circle Health

DI: 00860383000307 · Model: LMBCS20A99 · PWL SOLUTIONS LLC

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

3

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Basic Information

Brand Name: Complete Circle Health
Primary DI: 00860383000307
Version / Model: LMBCS20A99
Company Name: PWL SOLUTIONS LLC
Labeler DUNS: 080312287
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 3
Record Status: Published
Publish Date: 2016-09-24
Public Version: 3
Public Version Date: 2020-01-20
Public Version Status: Update
Public Device Record Key: 39b088b4-ad1d-4373-b9f7-7bccb27589c8
Distribution End Date: 2017-12-31

Device Description

Home Midstream Pregnancy Test

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860383000307	GS1
Unit of Use	00860383000314	GS1

Customer Contacts

Phone: 855-444-2105
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	6.0	Millimeter

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 4 – 30 Degrees Celsius