FDA.reportPublic FDA data

Medline

Primary DI
40080196862543
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND70277
Catalog number
DYND70277
Device description
SYRINGE,EAR/ULCER, 3 OZ, STERILE
Published
2021-02-03
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

Contact Domains#

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
40080196862543PackageGS150In Commercial Distribution
10080196862542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019686254340080196862543
1008019686254210080196862542

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation kit, single-useA collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manual syringe and other accessory items. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Fluid Ounce
Total Volume90Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00861092002606CeaLogic Ratio Applicator KitRECIBIO, INC.KYZ2026-03-01
00850027492995NavägeRhinosystems, Inc.KYZ2026-02-23
50192253068854MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068860MonojectCardinal Health 200, LLCKYZ2026-01-29
50192253068885MonojectCardinal Health 200, LLCKYZ2026-01-29
50192253068892MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253007449MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007487MonojectCardinal Health 200, LLCKYZ2025-12-15
50192253007518MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007531MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007555MonojectCardinal Health 200, LLCKYZ2025-12-15
50192253007730MonojectCardinal Health 200, LLCKYZ2025-12-15
00850063139441Neil Medical Group Neil Medical GroupKYZ2025-12-08
05413765580970RECOTHROM SPRAY KITBAXTER HEALTHCARE CORPORATIONKYZ2025-12-01
50198956194647CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
50198956181548CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
00810180841931Syringes without Needle, Non-Toxic, Luer Slip, 20 ML Dynarex CorporationKYZ2025-05-30
00810180841948Syringes without Needle, Non-Toxic, Luer Slip, 60 MLDynarex CorporationKYZ2025-05-30
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10661392008400LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008417LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008424LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16