FDA.reportPublic FDA data

BD SafetyGlide

Primary DI
00382903033300
Brand
BD SafetyGlide
Company
BECTON, DICKINSON AND COMPANY
Model
303330
Catalog number
303330
Device description
SYRINGE ALRG SFTYGLD 1ML W/NDL 27X3/8 IB
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951254000SAFETYGLIDE NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic1995-10-07FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382903033301PackageGS125In Commercial Distribution
50382903033305PackageGS140In Commercial Distribution
00382903033300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290303330130382903033301
5038290303330550382903033305
00382903033300003829030333003829030333000382903033300

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.038Inch
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

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
00382903840120BD Introsyte Autoguard3840123840122016-10-20
00382903840083BD Introsyte-N Autoguard, BD Instaflash3840083840082016-10-20
00382903840106BD Introsyte Autoguard3840103840102016-10-20
00382903840113BD Introsyte Autoguard3840113840112016-10-20
50382903840217BD Introsyte-N, BD Instaflash3840213840212016-10-20
50382903840309BD Introsyte3840303840302016-10-20
50382903840316BD Introsyte-N3840313840312016-10-20
50382903840408BD Introsyte3840403840402016-10-20
50382903840507BD Introsyte3840503840502016-10-20
00382904411268BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay4411264411262018-05-25
00885403523437HemoSphere AltaALTAALL1ALTAALL12026-08-06
00885403523451HemoSphere AltaALTASR1ALTASR12026-08-06
00885403523475HemoSphere AltaALTACR1ALTACR12026-08-06
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05413206353712K-Pack IITerumo Europe NVFMI2026-10-28
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
00850091070037CoreCareCorecare Products Inc.FMI2026-09-11
00850091070051CoreCareCorecare Products Inc.FMI2026-09-11
00850091070068CoreCareCorecare Products Inc.FMI2026-09-11
00850091070099CoreCareCorecare Products Inc.FMI2026-09-11
00850091070112CoreCareCorecare Products Inc.FMI2026-09-11
00850091070136CoreCareCorecare Products Inc.FMI2026-09-11
00850091070150CoreCareCorecare Products Inc.FMI2026-09-11
00850091070174CoreCareCorecare Products Inc.FMI2026-09-11
00850091070198CoreCareCorecare Products Inc.FMI2026-09-11
00850091070228CoreCareCorecare Products Inc.FMI2026-09-11
00850091070471CoreCareCorecare Products Inc.FMI2026-09-11
00850091070495CoreCareCorecare Products Inc.FMI2026-09-11
00850091070518CoreCareCorecare Products Inc.FMI2026-09-11
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11
00850091070570CoreCareCorecare Products Inc.FMF2026-09-11
00850091070594CoreCareCorecare Products Inc.FMF2026-09-11
00850091070617CoreCareCorecare Products Inc.FMF2026-09-11
00850091070631CoreCareCorecare Products Inc.FMF2026-09-11
00850091070655CoreCareCorecare Products Inc.FMI2026-09-11
00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMI2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11