AccessGUDID - DEVICE: Biotronix Healthcare IV Catheters (00858835007929)

GUDID

Device Identifier (DI) Information

Brand Name: Biotronix Healthcare IV Catheters
Version or Model: GEP050020-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Primary DI Number: 00858835007929
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065762392 *Terms of Use

Device Description: IV CATHETER 20G X 1 1/4" PINK,

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":	Yes
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?
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142797	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Device Size Text, specify: 20G x 1 1/4"

Device Record Status

Public Device Record Key: f74d3938-8cc8-41e0-9377-931144e4a182
Public Version Date: December 24, 2019
Public Version Number: 2
DI Record Publish Date: October 03, 2019