FDA UDI In Commercial Distribution 🇺🇸 United States

Solventum™

DI: 00197998355400 · Model: 2346N · Solventum US LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10

Basic Information

Brand Name
Solventum™
Primary DI
00197998355400
Version / Model
2346N
Catalog Number
2346N
Company Name
Solventum US LLC
Labeler DUNS
119004140
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2026-02-15
Public Version
1
Public Version Date
2026-02-23
Public Version Status
New
Public Device Record Key
1a486e8c-29eb-426b-9fb7-35da07479034

Device Description

Solventum™ Conductive gel pads for defibrillation or cardioversion,2346N, 22,8 cm x 15,2 cm (9 IN/PO x 6 IN/PO), 10/CAR

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
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
Yes
PM Exempt
Yes
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
GYB Media, electroconductive

GMDN Terms

Code Name
11425 Electrode conductive medium

Identifiers

Type ID
Package 00197998355417
Primary 00197998355400
Unit of Use 00197998355387

Customer Contacts