FDA.report

Dover

Primary DI
10192253029253
Brand
Dover
Company
Cardinal Health 200, LLC
Model
898029
Catalog number
898029-
Device description
Barrel and Bulb Syringe, bulk, non-sterile
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KYZSYRINGE, IRRIGATING (NON DENTAL)

Product Code Classifications

CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253029251PrimaryGS10
10192253029253Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225302925150192253029251
1019225302925310192253029253

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
125
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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