AccessGUDID - DEVICE: Tile-T20 (00850038691110)

GUDID

Device Identifier (DI) Information

Brand Name: Tile-T20
Version or Model: PN0583-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tasso Inc.

Primary DI Number: 00850038691110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078431936 *Terms of Use

Device Description: No description.

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):	No
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?
64872	Dried blood spot collection receptacle IVD	A self-contained, pen-like device intended to be used by a healthcare professional at the point-of-care, or by a patient/layperson outside a clinical environment, to collect and contain a dried blood spot specimen for subsequent diagnostic testing or screening. The proximal end includes internal capillary tubes which draw the blood specimen into the device, where it is deposited onto one or multiple dried blood collection paper disc(s). It does not contain needles or a lancet. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNK	Container, Specimen Mailer And Storage, Non-Sterile

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 2b2fa692-0098-4b40-8a4d-4242d4d7fa94
Public Version Date: February 14, 2025
Public Version Number: 1
DI Record Publish Date: February 06, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
10850038691117	60	00850038691110	In Commercial Distribution
20850038691114	20	00850038691110	In Commercial Distribution
30850038691111	100	00850038691110	In Commercial Distribution

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-257-2370
Email: customerservice@tassoinc.com

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