AccessGUDID - DEVICE: Dimension® Reaction Vessels (00842768013928)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Reaction Vessels
Version or Model: 10445044
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RXV1A
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768013928
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Dimension® Heterogenous Immunoassay Module - Reaction Vessels (1000) and Waste Container Liners (5)

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?
63297	Laboratory waste receptacle liner IVD	A device made of disposable materials intended to be placed inside a reusable waste receptacle for the collection and containment of waste, including biologically-contaminated waste products, resulting from in vitro diagnostic procedures. It creates a barrier to contamination, reduces cleaning requirements, and protects the waste receptacle from damage. It is typically made of synthetic polymer materials and should be discarded, with its waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JMG	Radioimmunoassay (two-site solid phase), ferritin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3049c26f-f20e-4b1a-95e6-0dbe11f37c1a
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2018