FDA.reportPublic FDA data

US DIAGNOSTICS Pen Needles, 32G x 4MM, 50ea

Primary DI
00857513006339
Brand
US DIAGNOSTICS Pen Needles, 32G x 4MM, 50ea
Company
YIDOBIO Inc.
Model
100097
Device description
US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major brands of injection pens. This needle is a device for subcutaneous injection of medicines used for pen type of insulin syringe as subcutaneous injectables.
Published
2018-05-24
Public version status
New
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
K160575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160575000CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.2016-09-07FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857513006336PackageGS120In Commercial Distribution
20857513006333PackageGS15In Commercial Distribution
00857513006339PrimaryGS10
90857513006332Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085751300633610857513006336
2085751300633320857513006333
00857513006339008575130063398575130063390857513006339
9085751300633290857513006332

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

Regulatory Flags#

DUNS number
689512763
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857513006278US DIAGNOSTICS Pen Needles, 31G x 5MM1000912018-01-01
00857513006285US DIAGNOSTICS Pen Needles, 31G x 6MM1000922018-01-01
00857513006292US DIAGNOSTICS Pen Needles, 31G x 8MM1000932018-01-01
00857513006308US DIAGNOSTICS Pen Needles, 32G x 4MM1000902018-01-01
00857513006346US DIAGNOSTICS Pen Needles, 32G x 5MM, 50ea1001012018-05-24
00857513006353US DIAGNOSTICS Pen Needles, 32G x 6MM, 50ea1001022018-05-24
00857513006360US DIAGNOSTICS Pen Needles, 31G 5MM, 50ea1000982018-05-24
00857513006377US DIAGNOSTICS Pen Needles, 31G x 6MM, 50ea1000992018-05-24
00857513006384US DIAGNOSTICS Pen Needles, 31G x 8MM, 50ea1001002018-05-24
20857513006272US DIAGNOSTICS Pen Needles, 31G x 5MM1000912018-01-01
20857513006289US DIAGNOSTICS Pen Needles, 31G x 6MM1000922018-01-01
20857513006296US DIAGNOSTICS Pen Needles, 31G x 8MM1000932018-01-01
20857513006302US DIAGNOSTICS Pen Needles, 32G x 4MM1000902018-01-01
20857513006333US DIAGNOSTICS Pen Needles, 32G x 4MM, 50ea1000972018-05-24
20857513006340US DIAGNOSTICS Pen Needles, 32G x 5MM, 50ea1001012018-05-24
20857513006357US DIAGNOSTICS Pen Needles, 32G x 6MM, 50ea1001022018-05-24
20857513006364US DIAGNOSTICS Pen Needles, 31G 5MM, 50ea1000982018-05-24
20857513006371US DIAGNOSTICS Pen Needles, 31G x 6MM, 50ea1000992018-05-24
20857513006388US DIAGNOSTICS Pen Needles, 31G x 8MM, 50ea1001002018-05-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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