FDA.reportPublic FDA data

AUM

Primary DI
00373317000064
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081225162
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
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
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
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
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
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27