FDA.reportPublic FDA data

BD Nano 2nd Gen Pen Needle

Primary DI
50382903205504
Brand
BD Nano 2nd Gen Pen Needle
Company
BECTON DICKINSON PEN LIMITED
Model
320550
Catalog number
320550
Device description
PEN NDL 32G 4MM PRO 100 BOX 1200 US
Published
2019-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212015000BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company2021-11-19FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903205504PackageGS112In Commercial Distribution
00382903205509PrimaryGS10
00382900550091Unit of UseGS10
80382903205505Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290320550450382903205504
00382903205509003829032055093829032055090382903205509
00382900550091003829005500913829005500910382900550091
8038290320550580382903205505

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Millimeter
Needle Gauge32Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
988402590
Device count
100
DM exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382905150630PhaSeal Optima5150635150632022-07-29
00382905153013BD PhaSeal5153015153012023-07-27
00382905152030BD PhaSeal5152035152032016-09-19
30382903205517BD Nano 2nd Gen3205513205512019-05-13
00382903201099BD Ultra-Fine3201093201092016-08-03
00382903201198BD Ultra-Fine3201193201192016-08-03
00382903201228BD Nano Ultra-Fine3201223201222016-08-03
00382903205509BD Nano 2nd Gen3205503205502019-05-08
00382903208807BD Ultra-Fine3208803208802016-08-03
00382903208814BD Ultra-Fine3208813208812016-08-03
00382903208821BD Ultra-Fine3208823208822016-08-03
00382903208838BD Nano Ultra-Fine3208833208832016-08-03
00382903282036BD Ultra-Fine3282033282032016-08-03
50382903205511BD Nano 2nd Gen3205513205512019-05-13
00382903201495BD Nano Ultra-Fine Pen Needles, 32G x 4MM (Sample)3201493201492016-08-03
00382903203673BD Ultra-Fine Pen Needles, 31G x 5MM (Sample)3203673203672016-08-03
00382903209811Pen Needles, 31G x 8MM3209813209812016-11-08
00382903209828Rite Aid Pen Needles, 31G x 5MM3209823209822016-11-10
00382903205400BD Nano Ultra-Fine Pen Needles, 32G x 4MM3205403205402017-08-15
50382905154053PhaSeal5154055154052023-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27