AccessGUDID - DEVICE: ATELLICA HA1C_E HIGH VOLUME BOTTLE KIT (00630414304304)

GUDID

Device Identifier (DI) Information

Brand Name: ATELLICA HA1C_E HIGH VOLUME BOTTLE KIT
Version or Model: 11597087
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11597087
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414304304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HA1C_E HIGH VOLUME BOTTLE KIT ATELLICA CH (5 BOTTLES)

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?
63042	Assay container IVD, reusable	A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures (e.g., rinsing of paraffin embedded tissues), or on-board automated liquid handling instruments or analysers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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
Special Storage Condition, Specify: without restrictions

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed04185e-272d-444a-a401-2b9074feca7c
Public Version Date: May 27, 2022
Public Version Number: 1
DI Record Publish Date: May 19, 2022