AccessGUDID - DEVICE: Introcan Safety ® 2 (04046955746101)

GUDID

Device Identifier (DI) Information

Brand Name: Introcan Safety ® 2
Version or Model: 4242010-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4242010-02
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046955746101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Introcan Safety® 2 IV Catheter - 20 Ga. x 2.0 in.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	Active	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 [?]
K220756	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: Catheter-Gauge : 20

Device Record Status

Public Device Record Key: 7610e2ec-530d-4f1b-975d-a264967c4d0f
Public Version Date: February 09, 2024
Public Version Number: 1
DI Record Publish Date: February 01, 2024