AccessGUDID - DEVICE: NOVEOS Substrate Mix Container Pack (00816879023091)

GUDID

Device Identifier (DI) Information

Brand Name: NOVEOS Substrate Mix Container Pack
Version or Model: 118877-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HYCOR BIOMEDICAL LLC

Primary DI Number: 00816879023091
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010558476 *Terms of Use

Device Description: No description.

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):	Yes
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?
35413	General laboratory container, reusable	A container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), biological specimens, and other materials associated with in the laboratory; it is not intended for in vitro diagnostic procedures. It is designed to withstand an extremely high-temperature environment (e.g., autoclaving) to enable repeated sterilization. It is typically made of high-temperature-resistant plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers (e.g., tissue culture). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DHB	System, Test, Radioallergosorbent (Rast) Immunological
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182479	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: b4b94db6-ef4a-4e0a-80c6-4049dabdaefb
Public Version Date: August 19, 2024
Public Version Number: 3
DI Record Publish Date: January 11, 2021