AccessGUDID - DEVICE: SAFESITE® (04045928016036)

GUDID

Device Identifier (DI) Information

Brand Name: SAFESITE®
Version or Model: 415066
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 415066
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04045928016036
Issuing Agency: GS1
Commercial Distribution End Date: August 12, 2022
Device Count: 100
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: RV1000FC REFLUX VLVEHINGE CAP

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?
42743	Negative-pressure intravenous line needleless valve-connector	A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point negative pressure from the device causes a small volume of retrograde fluid flow into the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

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: 1ca80724-0906-4eb8-843b-99c4a71a768d
Public Version Date: August 17, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016