FDA.reportPublic FDA data

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

Primary DI
20857513006333
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
Rx
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689512763
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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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