BD Nexiva, BD Q-Syte 383540

GUDID 50382903835404

NEXIVA 18GA 1.75IN HF Y

BECTON, DICKINSON AND COMPANY

Peripheral vascular catheter

Primary Device ID	50382903835404
NIH Device Record Key	08e1b2bd-539f-4c13-96ba-bc91907dd8cb
Commercial Distribution Status	In Commercial Distribution
Brand Name	BD Nexiva, BD Q-Syte
Version Model Number	383540
Catalog Number	383540
Company DUNS	124987988
Company Name	BECTON, DICKINSON AND COMPANY
Device Count	20
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Length	45 Millimeter
Total Volume	0.6 Milliliter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile, handle with care

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903835409 [Unit of Use]
GS1	30382903835400 [Primary]
GS1	50382903835404 [Package] Contains: 30382903835400 Package: Case [4 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K102520

FDA Product Code

FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-16

On-Brand Devices [BD Nexiva, BD Q-Syte]

50382903835404	NEXIVA 18GA 1.75IN HF Y
50382903835398	NEXIVA 18GA 1.25IN HF Y
50382903835381	NEXIVA 20GA 1.75IN HF Y
50382903835374	NEXIVA 20GA 1.25IN HF Y
50382903835367	NEXIVA 20GA 1.00IN HF Y
50382903835329	NEXIVA 22GA 1.00IN Y
50382903835312	NEXIVA 24GA 0.75IN Y
50382903835305	NEXIVA 24GA 0.56IN Y