FDA.reportPublic FDA data

Bulb Irrigation Syringe with Protective Cap Tubing Adaptor, Sterile,60 cc

Primary DI
00616784426112
Brand
Bulb Irrigation Syringe with Protective Cap Tubing Adaptor, Sterile,60 cc
Company
Dynarex Corporation
Model
4261
Device description
Sterile-EO
Published
2022-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784426136PackageGS150In Commercial Distribution
00616784426112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784426136006167844261366167844261360616784426136
00616784426112006167844261126167844261120616784426112

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
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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
00616784201528Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, Blue20152021-09-01
00616784201627Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, Blue20162021-09-01
00616784206226Lab Coats Knitted Cuffs & Collar with Pockets, Small, White20622021-09-01
00616784206325Lab Coats Knitted Cuffs & Collar with Pockets, Medium, White20632021-09-01
00616784206424Lab Coats Knitted Cuffs & Collar with Pockets, Large, White20642021-09-01
00616784206523Lab Coats Knitted Cuffs & Collar with Pockets, X-Large, White20652021-09-01
00616784206622Lab Coats Knitted Cuffs & Collar with Pockets, 2X-Large, White20662021-09-01
00616784207223Lab Coats Knitted Cuffs & Collar with Pockets, Small, Blue20722021-09-01
00616784207322Lab Coats Knitted Cuffs & Collar with Pockets, Medium, Blue20732021-09-01

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