AccessGUDID - DEVICE: ATELLICA HA1C_E HIGH VOLUME LABEL KIT (00630414304311)

GUDID

Device Identifier (DI) Information

Brand Name: ATELLICA HA1C_E HIGH VOLUME LABEL KIT
Version or Model: 11597090
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11597090
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414304311
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 LABEL KIT ATELLICA CH (50 LABELS)

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:	Yes
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?
63375	Printer label IVD	A thin, blank sheet of fibrous material, typically with an adhesive underside, intended to be imprinted with an image/text using a printer, and then applied to an object for identification (e.g., barcode) or information associated with an in vitro diagnostic procedure. It is typically available as a continuous roll with individual labels arranged on a waxy backing sheet for easy peeling. This is a single-use 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: 87c2ec7b-f1ca-4ec1-bf1f-6d8200ff9774
Public Version Date: May 27, 2022
Public Version Number: 1
DI Record Publish Date: May 19, 2022