FDA.reportPublic FDA data

AUM

Primary DI
00373317628558
Brand
AUM
Company
Slv Pharmaceuticals LLC
Model
MINI PEN NEEDLES 32G - 5MM
Device description
AUM MINI PEN NEEDLES 32G - 5MM
Published
2022-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K170846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170846000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00373317628558PrimaryGS10
00373317000088Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00373317628558003733176285583733176285580373317628558
00373317000088003733170000883733170000880373317000088

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.

Regulatory Flags#

DUNS number
081225162
Device count
100
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00373317624512AUMSAFETY PEN NEEDLES 32G -4MM2022-03-08
00373317628442AUMMINI PEN NEEDLES 31G - 4MM2022-03-08
00373317628459AUMMINI PEN NEEDLES 31G - 5MM2022-03-08
00373317628466AUMMINI PEN NEEDLES 31G - 6MM2022-03-08
00373317628480AUMMINI PEN NEEDLES 31G - 8MM2022-03-08
00373317628541AUMMINI PEN NEEDLES 32G - 4MM2022-03-08
00373317628565AUMMINI PEN NEEDLES 32G - 6MM2022-03-08
00373317628589AUMMINI PEN NEEDLES 32G - 8MM2022-03-08
00373317628640AUMMINI PEN NEEDLES 33G - 4MM2022-03-08
00373317628657AUMMINI PEN NEEDLES 33G - 5MM2022-03-08
00373317628664AUMMINI PEN NEEDLES 33G - 6MM2022-03-08
00373317464712BREATH COMFORTHUMIDIFIER2022-03-08
00373317495211BREATHE COMFORT OPTICHAMBERS2022-03-08
00373317495228BREATHE COMFORT OPTICHAMBERS2022-03-08
00373317568212AUMMOISTURIZING GEL SOCKS 2022-03-08
00373317000064AUMSAFETY PEN NEEDLES 32G -4MM2022-03-08
00373317000033AUMMINI PEN NEEDLES 31G - 4MM2022-03-08
00373317000026AUMMINI PEN NEEDLES 31G - 5MM2022-03-08
00373317000057AUMMINI PEN NEEDLES 31G - 6MM2022-03-08
00373317000040AUMMINI PEN NEEDLES 31G - 8MM2022-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16972857297791Easydrip PentaGlider Plus Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
20192253036999MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037033MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037064MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037071MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037101MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037125MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037132MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037156MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037194MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037200MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037255MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037262MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037279MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038269MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038283MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038290MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038313MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038368MonojectCardinal Health 200, LLCFMI2026-07-09
00857273002602droplet® pen needlesHTL STREFA S AFMI2026-07-05
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08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31