FDA.reportPublic FDA data

Dover

Primary DI
30884521008094
Brand
Dover
Company
Cardinal Health, Inc.
Model
67800
Catalog number
67800
Device description
Irrigation Tray with Bulb Syringe
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
30884521008094PackageGS120In Commercial Distribution
10884521008090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452100809430884521008094
1088452100809010884521008090

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This side up;

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841767195717Trinity Sterile, Inc.Trinity Sterile, Inc.KYZ2026-08-25
10080196456765MEDLINEMEDLINE INDUSTRIES, INC.KYZ2026-07-14
10080196031764MEDLINEMEDLINE INDUSTRIES, INC.KYZ2026-07-13
10198956501645CARDINAL HEALTHCardinal Health 200, LLCKYZ2026-06-08
10198956466579CARDINAL HEALTHCardinal Health 200, LLCKYZ2026-05-19
10653160392859Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KYZ2026-04-08
10192253068856MonojectCardinal Health 200, LLCKYZ2026-01-29
10192253068863MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068884MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068891MonojectCardinal Health 200, LLCKYZ2026-01-29
10192253007442MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007480MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007510MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007534MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007558MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007732MonojectCardinal Health 200, LLCKYZ2025-12-15
00661392004474LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392007437LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392010734LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392010758LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392055124LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392055155LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
10198956204768CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-10
10198956194649CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
10198956181540CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
10704411006152AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007074AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007098AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
00661392002258LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002265LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16