FDA UDI In Commercial Distribution 🇺🇸 United States

DEFENDO Air/Water and Suction Valves

DI: 00724995246815 · Model: 100317 · MEDIVATORS INC.
Product Codes
2
GMDN Terms
2
Identifiers
4
Pkg Device Count
1

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Basic Information

Brand Name
DEFENDO Air/Water and Suction Valves
Primary DI
00724995246815
Version / Model
100317
Catalog Number
100317
Company Name
MEDIVATORS INC.
Labeler DUNS
068199363
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-06
Public Version
1
Public Version Date
2026-04-14
Public Version Status
New
Public Device Record Key
4345128d-f218-4610-a2f8-56af2b5fa783

Device Description

Defendo Pentax Single Use Air-Water and Suction Valve 2-piece kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
ODC Endoscope channel accessory
FDF Colonoscope and accessories, flexible/rigid

GMDN Terms

Code Name
60758 Endoscope air/water valve, single-use
60759 Endoscope suction valve, single-use

Identifiers

Type ID
Package 50724995246810
Package 10724995246812
Primary 00724995246815
Previous 00677964055935

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K102409 000
K102581 000
K232004 000