AccessGUDID - DEVICE: N Predilution Wells (00842768012174)

GUDID

Device Identifier (DI) Information

Brand Name: N Predilution Wells
Version or Model: 10446521
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OVIC11
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768012174
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1100
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: The N Predilution Well is used for settings of dilutions of standards, controls and sera.

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?
62225	Assay container IVD, single-use	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, or on-board automated liquid handling instruments or analysers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DEW	IGG, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943997	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f346df64-b9d6-4604-8c68-6606d81e745e
Public Version Date: March 05, 2024
Public Version Number: 6
DI Record Publish Date: October 31, 2017