AccessGUDID - DEVICE: OSOM Ultra Flu Aspirate 25T Kit (00742860100239)

GUDID

Device Identifier (DI) Information

Brand Name: OSOM Ultra Flu Aspirate 25T Kit
Version or Model: 1007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1007
Company Name: SEKISUI DIAGNOSTICS, LLC

Primary DI Number: 00742860100239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 966812344 *Terms of Use

Device Description: OSOM Ultra Flu Aspirate 25T Kit

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:	Yes
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?
57954	Nasopharyngeal aspirate container IVD	A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a nasopharyngeal aspirate specimen for culture, analysis, and/or other investigation. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PSZ	Devices detecting influenza A, B, and C virus antigens

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
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b29495a-85cd-4cdd-9ede-f0df1133dd4a
Public Version Date: January 22, 2021
Public Version Number: 4
DI Record Publish Date: January 10, 2017