AccessGUDID - DEVICE: Atellica IM CsA PRE Pretreatment (00630414598765)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM CsA PRE Pretreatment
Version or Model: 10995552
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995552
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414598765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Cyclosporine (CsA) Pretreatment Atellica IM - CONS (2PK) 2 x 26mL

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?
55441	Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKW	CYCLOSPORINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071455	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 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Protect from light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac2cc71f-1137-40a8-b569-aff4b2cbd8d0
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: February 06, 2018