AccessGUDID - DEVICE: InActiv Blue (05411967003464)

GUDID

Device Identifier (DI) Information

Brand Name: InActiv Blue
Version or Model: IB_TUB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fertipro NV

Primary DI Number: 05411967003464
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 373904101 *Terms of Use

Device Description: InActiv Blue is a pathogen-inactivating and DNA/RNA stabilizing medium used for transport of naso- or oropharyngeal swabs, or saliva sampled from patients for in vitro diagnostic testing on the presence of genetic material of a virus by RT-qPCR or other molecular method (SARS-CoV-2, Influenza A/B, RSV A/B).

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?
62392	Oral/respiratory tract specimen container IVD, additive/medium	A covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBD	Microbial Nucleic Acid Storage And Stabilization Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221547	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
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: e76f535c-18e9-469b-93b8-1b19a1401b93
Public Version Date: August 22, 2024
Public Version Number: 1
DI Record Publish Date: August 14, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05411967003471	50	05411967003464	In Commercial Distribution	Rack
05411967003778	400	05411967003464	In Commercial Distribution	Carboard box
05411967003488	1200	05411967003464	In Commercial Distribution	Carboard box