AccessGUDID - DEVICE: Tasso-M20 (00860006434540)

GUDID

Device Identifier (DI) Information

Brand Name: Tasso-M20
Version or Model: K1001-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tasso Inc.

Primary DI Number: 00860006434540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078431936 *Terms of Use

Device Description: The Tasso-M20 is used to collect, store, and transport capillary blood for testing in a centralized laboratory. It is to be used in non-clinical settings for use in adult populations.

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?
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
NNK	Container, Specimen Mailer And Storage, Non-Sterile
FMK	Lancet, Blood

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: Yes
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: 95985f1e-7b2b-4060-ad10-9e446d8847f7
Public Version Date: August 20, 2024
Public Version Number: 3
DI Record Publish Date: July 20, 2021