FDA.reportPublic FDA data

Post Medical, Inc.

Primary DI
B3093301LPR1
Brand
Post Medical, Inc.
Company
POST MEDICAL, INC.
Model
3301-LPR
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K925816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925816000SHARPS CONTAINMENT SYSTEMPost Medical, Inc.1994-04-29FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3093301LPR1PackageHIBCC12In Commercial Distribution
B3093301LPR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sharps containerA device designed as a container to allow the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically be incineration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968012943
Device count
1
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
false
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
B3091G0Post Medical, Inc.1G2016-09-25
B3092201LPBW0Post Medical, Inc.2201-LPBW2016-09-20
B3092201LPBWY0Post Medical, Inc.2201-LPBW-Y2016-09-20
B3092201LPR0Post Medical, Inc.2201-LPR2016-09-20
B3092G0Post Medical, Inc.2G2016-09-25
B3092GY0Post Medical, Inc.2GY2016-09-25
B3093301LPR0Post Medical, Inc.3301-LPR2016-09-20
B3093G0Post Medical, Inc.3G2016-09-25
B309PMSM9500Post Medical, Inc.PMSM-9502016-09-20
B309SL1000Post Medical, Inc.SL-1002016-09-20
B309SL1500Post Medical, Inc.SL-1502016-09-20
B309SL2000Post Medical, Inc.SL-2002016-09-20
B309WD1100Post Medical, Inc.WD-1102016-09-20
B309WD1500Post Medical, Inc.WD-1502016-09-20
B309WD200Y0Post Medical, Inc.WD200Y2016-09-17
00761059015017Universal Sharps ContainerSC00152022-02-20
B3091101LPBW0Post Medical, Inc.1101-LPBW2016-09-12
B3091101LPR0Post Medical, Inc.1101LPR2016-09-12
B309WD2000Post Medical, Inc.WD-200WD-2002016-09-07
B3091G1Post Medical, Inc.1G2016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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20192253038290MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038313MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038368MonojectCardinal Health 200, LLCFMI2026-07-09
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