FDA.report

Medline

Primary DI
40080196031796
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND20300
Catalog number
DYND20300
Device description
TRAY,IRRIGATION,PISTON SYRINGE,60ML
Published
2021-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KYZSYRINGE, IRRIGATING (NON DENTAL)

Product Code Classifications

CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196031796PackageGS120In Commercial Distribution
10080196031795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019603179640080196031796
1008019603179510080196031795

GMDN Terms

TermDefinition
Wound irrigation kit, sterileA collection of sterile devices intended to be used to irrigate/cleanse an acute or chronic external wound. It consists of multiple items which typically include an irrigation instrument (e.g., syringe, bulb), wipes, towel, drape and/or irrigation solution. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10197344039845MEDLINEHNY19150HNY191502024-10-11
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10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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