AccessGUDID - DEVICE: SURECAN SAFETY II (04046955156221)

GUDID

Device Identifier (DI) Information

Brand Name: SURECAN SAFETY II
Version or Model: 4447045-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4447045-02
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046955156221
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 with Caresite® Y injection site 19G x 0.6in. (15mm)

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
No Device Sizes

Device Record Status

Public Device Record Key: c6033fd3-d6e9-4108-9bd7-4d43f7198296
Public Version Date: March 03, 2020
Public Version Number: 3
DI Record Publish Date: December 07, 2018