AccessGUDID - DEVICE: Northeast Laboratory Services (00810144911151)

GUDID

Device Identifier (DI) Information

Brand Name: Northeast Laboratory Services
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T1300
Company Name: Northeast Laboratory Services, Inc.

Primary DI Number: 00810144911151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071749709 *Terms of Use

Device Description: Cooked Meat Medium

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):	No
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?
58688	Enriched agar culture medium IVD	An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZI	Culture Media, Enriched

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00ba68cd-439a-473c-8676-b682ceaee97f
Public Version Date: September 29, 2023
Public Version Number: 1
DI Record Publish Date: September 21, 2023