AccessGUDID - DEVICE: ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated (00630414553191)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated
Version or Model: 10283347
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6860523
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414553191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Phosphorus inorganic - ADVIA Chem. - Conc. RGT - 6x1700 tests

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):	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?
59123	Inorganic phosphate (PO43-) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEO	Phosphomolybdate (colorimetric), inorganic phosphorus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991576	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
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12f15dd8-a0bf-4f33-b83b-20dd3b75d80d
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2020