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

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00616784431420Senior Tongue Depressors, 6" (15.2 cm)43142021-09-01
00616784435213Gait Belt, Natural Colors, Metal Buckle, 60" x 2"43522021-09-01
00616784435312Gait Belt, Multicolor, Metal Buckle, 60" x 2"43532021-09-01
00616784435411Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2"43542021-09-01
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
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00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01

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