FDA.reportPublic FDA data

Diversatek Healthcare

Primary DI
M78312011110
Brand
Diversatek Healthcare
Company
DIVERSATEK HEALTHCARE, INC.
Model
1201-111
Catalog number
1201-111
Device description
Fujifilm 5-pc Valve Kit
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
OCXEndoscopic Irrigation/Suction System
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M78312011111PackageHIBCC50In Commercial Distribution
M78312011110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel support kitA collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags#

DUNS number
030650113
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816734021286InnerVision®1465-401465-402018-09-18
00816734021293InnerVision®1465-501465-502018-09-18
00816734021217InnerVision®1450-021450-022018-09-18
00816734021224InnerVision®1450-401450-402018-09-18
00816734021231InnerVision®1450-501450-502018-09-18
00816734021248InnerVision®1450-561450-562018-09-18
00816734021255InnerVision®1455-401455-402018-09-18
00816734021262InnerVision®1455-501455-502018-09-18
00816734021279InnerVision®1455-561455-562018-09-18
00816734021309InnerVision®1465-561465-562018-09-18
00816734023518BullDog®1203-401203-402025-12-05
10816734023515BullDog®1203-401203-402025-12-05
M78312011160Diversatek Healthcare1201-1161201-1162025-11-14
00816734021682Diversatek HealthcareA86-1070A86-10702023-06-30
00816734021835Diversatek HealthcareA86-4300-10A86-4300-102023-06-30
00816734021859Diversatek HealthcareA86-5070A86-50702023-06-30
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16

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