AccessGUDID - DEVICE: BD Prefilled Normal Saline with Blunt Plastic Cannula (00382903065189)

GUDID

Device Identifier (DI) Information

Brand Name: BD Prefilled Normal Saline with Blunt Plastic Cannula
Version or Model: 306518
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 306518
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382903065189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: NORMAL SALINE 10ML FILL IN 10ML SYR W/BP

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):	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?
64786	Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial	A solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. 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 [?]
K011982	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: 30959d5a-f422-4bbd-a7a4-9cad507a5230
Public Version Date: May 20, 2024
Public Version Number: 4
DI Record Publish Date: September 16, 2016