FDA.report

BD Nexiva™ Closed IV Catheter System with NearPort™ IV Access

Primary DI
30382903935261
Brand
BD Nexiva™ Closed IV Catheter System with NearPort™ IV Access
Company
BECTON, DICKINSON AND COMPANY
Model
393526
Catalog number
393526
Device description
NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO
Published
2023-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FOZCatheter, intravascular, therapeutic, short-term less than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30382903935261PackageGS120In Commercial Distribution
50382903935265PackageGS14In Commercial Distribution
00382903935260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290393526130382903935261
5038290393526550382903935265
00382903935260003829039352603829039352600382903935260

GMDN Terms

TermDefinition
Peripheral intravenous cannulaA short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods

Method

Regulatory Flags

DUNS number
124987988
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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