FDA.reportPublic FDA data

AUM

Primary DI
00373317624512
Brand
AUM
Company
Slv Pharmaceuticals LLC
Model
SAFETY PEN NEEDLES 32G -4MM
Device description
AUM SAFETY PEN NEEDLES 32G -4MM
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
K210864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210864000Safety Pen NeedleSandstone Medical (Suzhou), Inc.2022-02-17FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00373317624512PrimaryGS10
00373317000064Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00373317624512003733176245123733176245120373317624512
00373317000064003733170000643733170000640373317000064

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. 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
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
00373317628558AUMMINI PEN NEEDLES 32G - 5MM2022-03-08
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
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27