FDA.reportPublic FDA data

BD PrecisionGlide

Primary DI
00382903051076
Brand
BD PrecisionGlide
Company
BECTON, DICKINSON AND COMPANY
Model
305107
Catalog number
305107
Device description
NEEDLE 30GA 1/2IN
Published
2023-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston
FMINeedle, hypodermic, single lumen
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021475000BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETBd2002-07-19FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382903051077PackageGS1100In Commercial Distribution
50382903051071PackageGS110In Commercial Distribution
00382903051076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290305107730382903051077
5038290305107150382903051071
00382903051076003829030510763829030510760382903051076

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Regulatory Flags#

DUNS number
001292192
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403523512HemoSphere AltaHEMA70CC2HEMA70CC22026-09-18
00885403523536HemoSphere AltaHEMAPSC200HEMAPSC2002026-09-18
00885403533122ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKBB64EKBB2026-09-18
00885403533146TruWave Reusable Cable64EKGE164EKGE12026-09-18
00885403533153ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKGE264EKGE22026-09-18
00885403533160TruWave Reusable Cable64EKH64EKH2026-09-18
00885403533610TruWave Reusable Cable70ANHS70ANHS2026-09-18
00885403533634Pressure Slave Cable70ANS70ANS2026-09-18
00885403533641Cable COO Catheter Interface70CC270CC22026-09-18
00885403533665TruWave Reusable CablePX15S162PX15S1622026-09-18
00885403533764Smart Pressure ControllerPC1QPC1Q2026-09-18
00885403533771Smart Pressure Controller Accessory KitPC1QAKPC1QAK2026-09-18
00885403543282TruWave Reusable CablePX12S162PX12S1622026-09-18
00885403543299TruWavePX17S162PX17S1622026-09-18
00885403543305TruWavePX21S162PX21S1622026-09-18
00885403543312TruWavePX6D162PX6D1622026-09-18
00885403543428TruWavePX6T162PX6T1622026-09-18
00885403543435TruWavePX2D162PX2D1622026-09-18
00885403543459TruWavePX11T162PX11T1622026-09-18
00885403543466TruWavePX7D162PX7D1622026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070280CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070297CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020788Precision PointGold Coast Medical Supply, LPFMI2026-08-26