AccessGUDID - DEVICE: Atellica™ IM RBC FOL (00630414597690)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica™ IM RBC FOL
Version or Model: 10995440
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995440
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414597690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RBC Folate - Atellica IM - CONS - 4 x 30mL

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?
43518	Dithiothriotol (DTT) reagent IVD	A dithiothriotol (DTT) solution intended to be used alone or in combination with other IVDs for reducing disulphide bridges in peptides present in clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGN	ACID, FOLIC, RADIOIMMUNOASSAY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172201	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: Store upright

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b1fc077-1932-4543-91f3-638e25e7739c
Public Version Date: June 07, 2024
Public Version Number: 6
DI Record Publish Date: June 05, 2018