AccessGUDID - DEVICE: BD PosiFlush SafeScrub (50382903031912)

GUDID

Device Identifier (DI) Information

Brand Name: BD PosiFlush SafeScrub
Version or Model: 303191
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 303191
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 50382903031912
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 480
Labeler D-U-N-S® Number*: 007263197 *Terms of Use

Device Description: SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
61142	Vascular access device flush/disinfection tool	A manual device intended to be used to flush wash the lumen of an in situ vascular access device (e.g., catheter, needleless intravenous line) and to disinfect the device’s Luer access valve. It consists of a prefilled syringe containing a saline solution, and a disinfection cap or scrubber containing a foam material saturated with disinfectant [e.g., isopropyl alcohol (IPA)]. It may be supplied as a one-piece or modular device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QTI	Saline Vascular Access Flush with integrated Alcohol Disinfectant Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213955	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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c784cc9c-1677-432d-8452-05848eadf521
Public Version Date: October 13, 2022
Public Version Number: 1
DI Record Publish Date: October 05, 2022