FDA.reportPublic FDA data

BD Ultra-Fine

Primary DI
00382903208807
Brand
BD Ultra-Fine
Company
BECTON DICKINSON PEN LIMITED
Model
320880
Catalog number
320880
Device description
BD Ultra-Fine Pen Needles, 12.7mm, 29G, 3bevel, TW
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K213478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213478000BD Pen NeedleBecton, Dickinson and Company2022-06-28FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903208802PackageGS112In Commercial Distribution
00382903208807PrimaryGS10
80382903208803Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290320880250382903208802
00382903208807003829032088073829032088070382903208807
8038290320880380382903208803

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
Length12.7Millimeter
Needle Gauge29Gauge

Regulatory Flags#

DUNS number
988402590
Device count
90
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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
30382905154035BD PhaSeal5154035154032023-09-15

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