FDA UDI In Commercial Distribution 🇺🇸 United States

Diversatek Healthcare

DI: M78312011110 · Model: 1201-111 · DIVERSATEK HEALTHCARE, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Diversatek Healthcare
Primary DI
M78312011110
Version / Model
1201-111
Catalog Number
1201-111
Company Name
DIVERSATEK HEALTHCARE, INC.
Labeler DUNS
030650113
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-10
Public Version
1
Public Version Date
2025-01-20
Public Version Status
New
Public Device Record Key
5723a39d-af4c-40e2-b464-17424fa75e47

Device Description

Fujifilm 5-pc Valve 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
Yes
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
No
Sterilization Prior Use
No

Product Codes

Code Name
OCX Endoscopic Irrigation/Suction System
ODC Endoscope Channel Accessory
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope

GMDN Terms

Code Name
60760 Endoscope channel support kit

Identifiers

Type ID
Package M78312011111
Primary M78312011110

Customer Contacts

Phone
800-558-6408