DEVICE: Drew Scientific (00817274020326)

Device Identifier (DI) Information

Drew Scientific
EXA-339+
In Commercial Distribution

DREW SCIENTIFIC, INC.
00817274020326
GS1

1
144968104 *Terms of Use
Control Kit, 3-Level (9 x 3ml)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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?
31523 Total lipoprotein IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total lipoprotein lipid in a clinical specimen.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JPK Mixture, Hematology Quality Control
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K003874 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

48291061-e7d3-4ee5-b87a-7ef306598a9b
July 06, 2018
3
September 09, 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)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-305-324-2300
customersupport@erbadiagnostics.com
CLOSE