FDA UDI In Commercial Distribution 🇺🇸 United States

DEFENDO Air/Water/Suction and Biopsy Valve

DI: 00724995246808 · Model: 100316 · MEDIVATORS INC.
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
1

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Basic Information

Brand Name
DEFENDO Air/Water/Suction and Biopsy Valve
Primary DI
00724995246808
Version / Model
100316
Catalog Number
100316
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
2c8d264b-d619-4fa3-84ba-218bd1a458e9

Device Description

3-piece kit, Single-Use Air Water, Suction and Biopsy Valves - Pentax

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
60760 Endoscope channel support kit

Identifiers

Type ID
Package 10724995246805
Primary 00724995246808
Package 50724995246803
Previous 00677964055928

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K090851 000
K102409 000
K102581 000
K232004 000