FDA.report

BD Nokor

Primary DI
50382903052016
Brand
BD Nokor
Company
BECTON, DICKINSON AND COMPANY
Model
305201
Catalog number
305201
Device description
NEEDLE FILTER NOKOR 18X1-1/2 TW
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50382903052016PackageGS110In Commercial Distribution
30382903052012PrimaryGS10
00382903052011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290305201650382903052016
3038290305201230382903052012
00382903052011003829030520113829030520110382903052011

GMDN Terms

TermDefinition
Medication transfer needle, filteringA sterile, slender, sharply-pointed metal tube typically intended to be used in the pharmacy to transfer medication from a vial to another container. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient-administered medication. This is a single-use device.

Device Sizes

TypeValueUnit
Length1.5Inch
Needle Gauge18Gauge

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods

Method

Regulatory Flags

DUNS number
001292192
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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