AccessGUDID - DEVICE: Fresh Cells (30014613335603)

GUDID

Device Identifier (DI) Information

Brand Name: Fresh Cells
Version or Model: C49-0102A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C49-0102A
Company Name: DIAGNOSTIC HYBRIDS, INC.

Primary DI Number: 30014613335603
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117359612 *Terms of Use

Device Description: CITES KIDNEY RHESUS SV W/C AN

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Cell culture line IVD	A cell line of known origin intended to be used alone or in combination with other IVDs, for cytogenetic analyses and/or for the detection/cultivation of viruses present in clinical laboratory specimens.

FDA Product Code

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Product Code	Product Code Name
KIR	CELLS, ANIMAL AND HUMAN, CULTURED

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: No
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: 7fea072d-1637-4815-ad7f-371839358aab
Public Version Date: October 22, 2018
Public Version Number: 1
DI Record Publish Date: September 21, 2018