DEVICE: Easy Plus II (04719871820063)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Easy Plus II
6276-S(BYG60276HA)
Not in Commercial Distribution

BIOTEST MEDICAL CORPORATION
04719871820063
GS1
May 02, 2016
1
658447255 *Terms of Use
Easy Plus II Glucose Meter, 6276-S
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
56685 Glucose analyser IVD, home-use/point-of-care, line-powered
A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the quantitative in vitro measurement of glucose levels in whole blood. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
CGA Glucose Oxidase, Glucose
NBW System, Test, Blood Glucose, Over The Counter
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
ae121415-9db3-4083-9f74-2944d0dad1c4
March 29, 2018
2
May 02, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE