AccessGUDID - DEVICE: TIC® 20 µL Capillary Pack (Glass) (04061609000521)

GUDID

Device Identifier (DI) Information

Brand Name: TIC® 20 µL Capillary Pack (Glass)
Version or Model: TIC-CP20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOANALYTIC GmbH, biomed. Analysentechnik

Primary DI Number: 04061609000521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 327536728 *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:	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?
57893	Microcapillary blood collection tube IVD, no additive	A non-sterile glass or plastic microcollection tube, typically sealed at one or both ends with a putty-like substance following specimen collection, containing no additive. It is intended to be used for the collection, and preservation and/or transport, of capillary blood for analysis or other investigation (e.g., neonatal bilirubin). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GIO	Tube, Collection, Capillary 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: 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
No Device Sizes

Device Record Status

Public Device Record Key: e2c0114b-714e-4d85-a46e-4ee4c6c7ddaa
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 06, 2018