AccessGUDID - DEVICE: Flame photometer standard 140 Na 5K (08426950001805)

GUDID

Device Identifier (DI) Information

Brand Name: Flame photometer standard 140 Na 5K
Version or Model: 00009751750
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00009751750
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950001805
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2019
Device Count: 50
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: Flame photometer standard 140 Na 5K

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?
52867	Multiple electrolyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJO	FLAME EMISSION PHOTOMETER FOR CLINICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K823480	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Calibration Standard 140/5/1 and 140/5 is stable until the expiration date if stored at 15-25 °C. The expiration date and lot number are printed on each vial and on the outer box.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 870083bb-0262-452f-b470-6d0bdc39e6d8
Public Version Date: July 07, 2021
Public Version Number: 6
DI Record Publish Date: September 23, 2016