AccessGUDID - DEVICE: Ion Torrent™Dx Sample Dilution Kit (10190302006323)

GUDID

Device Identifier (DI) Information

Brand Name: Ion Torrent™Dx Sample Dilution Kit
Version or Model: A32439
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES CORPORATION

Primary DI Number: 10190302006323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080131636 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	Yes
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?
58208	Buffered sample diluent IVD, manual	A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	CLINICAL SAMPLE CONCENTRATOR

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: 1a663b52-bef5-4300-a441-100998698402
Public Version Date: September 25, 2018
Public Version Number: 3
DI Record Publish Date: June 28, 2017