AccessGUDID - DEVICE: Tasso+ Convenience Kit (00860006434533)

GUDID

Device Identifier (DI) Information

Brand Name: Tasso+ Convenience Kit
Version or Model: K1011-04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Tasso Inc.

Primary DI Number: 00860006434533
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 078431936 *Terms of Use

Device Description: Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis.

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?
63061	Capillary blood collection system IVD	An assembly of devices intended to be used for the collection, preservation, and/or transportation of capillary blood for subsequent analysis and/or other investigation. It is a self-contained unit consisting of micro-needles and a container with a pre-measured amount of vacuum. The device is intended to be placed against the skin where the needles make shallow perforations, from which blood is drawn from the capillaries into the container via the vacuum. It may or may not contain a preservative or anticoagulant (e.g., lithium heparin). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 18 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7769b49-4d7c-47f4-8a36-6894e360a842
Public Version Date: August 20, 2024
Public Version Number: 4
DI Record Publish Date: May 10, 2021