FDA.reportPublic FDA data

Dialysis Safety Syringe w/Needle

Primary DI
00616784693125
Brand
Dialysis Safety Syringe w/Needle
Company
Dynarex Corporation
Model
6931
Published
2016-09-24
Public version status
Update
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
K052445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052445000DUOPROSS NEEDLEDuopross Meditech Corporation2005-12-05FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784693132PackageGS112In Commercial Distribution
00616784693125PrimaryGS10
00616784693118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784693132006167846931326167846931320616784693132
00616784693125006167846931256167846931250616784693125
00616784693118006167846931186167846931180616784693118

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis needleA sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117343764Dynacare Necessities Complete Kit13742026-05-28
00616784812137Drape Sheets, Tissue 2-ply, White, 40" x 48"81212021-09-01
00616784812236Drape Sheets81222021-09-01
00616784812335Drape Sheets81232021-09-01
00616784813134Drape Sheets, Tissue 2-ply, White, 40" x 60"81312021-09-01
00616784813233Drape Sheets81322021-09-01
00616784813332Drape Sheets81332021-09-01
00616784814131Drape Sheets, Tissue 2-ply, White81412021-09-01
00616784815039Drape Sheets, Tissue 2-ply, Blue, 40" x 90"81502021-09-01
00616784815138Drape Sheets, Tissue 2-Ply, white, 40" x 90"81512021-09-01
00616784816135Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White81612021-09-01
00616784890128SecureSafe Safety Insulin Syringe89012017-10-16
00616784890425SecureSafe Safety Insulin Syringe89042017-10-16
00616784892825SecureSafe Syringes With Safety Needle, Non-Toxic, 3 ML, Luer Lock89282017-10-16
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08

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Primary DI, Brand, Company table
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00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
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