AccessGUDID - DEVICE: SURECAN SAFETY II (04046955156306)

GUDID

Device Identifier (DI) Information

Brand Name: SURECAN SAFETY II
Version or Model: 4447009-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4447009-02
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046955156306
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Surecan™ Safety II Port Access Needle Set 20G x 1.5 in. (38mm)

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?
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTI	Non-Coring (Huber) Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Length of cannula (metric) : 38.000 MM
Device Size Text, specify: Gauge (cannula) : 20

Device Record Status

Public Device Record Key: 66434f6a-59c9-4040-b671-9765d50d384f
Public Version Date: March 03, 2020
Public Version Number: 7
DI Record Publish Date: December 22, 2017