BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

BD prefilled normal saline with blunt plastic cannula

DI: 00382903065240 · Model: 306524 · BECTON, DICKINSON AND COMPANY

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: BD prefilled normal saline with blunt plastic cannula
Primary DI: 00382903065240
Version / Model: 306524
Catalog Number: 306524
Company Name: BECTON, DICKINSON AND COMPANY
Labeler DUNS: 001292192
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-16
Public Version: 3
Public Version Date: 2024-05-20
Public Version Status: Update
Public Device Record Key: 0bf50733-628f-4de5-8df5-94fa75dd932d

Device Description

NORMAL SALINE 3ML FILL IN 3ML SYR W/BPC

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50382903065245	GS1	Case	4	In Commercial Distribution
Primary	00382903065240	GS1
Package	30382903065241	GS1	Shelfpack	30	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K011982	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 20 – 25 Degrees Celsius