DEVICE: NA (00816576020102)

Device Identifier (DI) Information

NA
G14
In Commercial Distribution
G14
HARDY DIAGNOSTICS
00816576020102
GS1

10
039981550 *Terms of Use
BHI AGAR with VANCOMYCIN (Brain Heart Infusion Agar with Vancomycin 6mcg/ml). For detecting vancomycin resistant Enterococcus spp. (VRE).
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
58699 VRE/HLARE agar culture medium IVD
A selective and/or differential agar culture medium containing specified concentrations of antimicrobials intended to be used to screen for the presence of Vancomycin-resistant Enterococci (VRE) and/or High Level Aminoglycoside Resistant Enterococci (HLARE) in a clinical specimen.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

60fe9299-7267-403e-a9fb-3559cf0a847a
March 29, 2018
2
September 01, 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: 00816576021215 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-266-2222
techservice@hardydiagnostics.com
CLOSE