AccessGUDID - DEVICE: ORTHO (10758750032846)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHO
Version or Model: 6842222
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6842222
Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.

Primary DI Number: 10758750032846
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068715424 *Terms of Use

Device Description: ORTHO Optix™ Reader ID-MTS Gel

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
64179	Agglutination assay digital imaging reader/analyser IVD	An electrically-powered laboratory instrument designed to be used to capture digital images of a clinical specimen from a dedicated specimen slide/cartridge/card and provide image analysis of an agglutination or haemagglutination assay. It is a benchtop instrument that includes a tray, slot or drawer, where the specimen is placed for optical image acquisition, and dedicated software for analysis, visualization and storage of the acquired images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSZ	SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY

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 -23.3 and 65.5 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad012eaa-a42f-42f4-aa74-60ac5630dae9
Public Version Date: October 24, 2022
Public Version Number: 2
DI Record Publish Date: April 07, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES