FDA.reportPublic FDA data

US DIAGNOSTICS Pen Needles, 31G 5MM, 50ea

Primary DI
00857513006360
Brand
US DIAGNOSTICS Pen Needles, 31G 5MM, 50ea
Company
YIDOBIO Inc.
Model
100098
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
10857513006367PackageGS120In Commercial Distribution
20857513006364PackageGS15In Commercial Distribution
00857513006360PrimaryGS10
90857513006363Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085751300636710857513006367
2085751300636420857513006364
00857513006360008575130063608575130063600857513006360
9085751300636390857513006363

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
Length5Millimeter
Needle Gauge31Gauge

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
00857513006339US DIAGNOSTICS Pen Needles, 32G x 4MM, 50ea1000972018-05-24
00857513006346US DIAGNOSTICS Pen Needles, 32G x 5MM, 50ea1001012018-05-24
00857513006353US DIAGNOSTICS Pen Needles, 32G x 6MM, 50ea1001022018-05-24
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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