FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 30653405015691 · Model: A228 · Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
30653405015691
Version / Model
A228
Catalog Number
A228
Company Name
Conmed Corporation
Labeler DUNS
071595540
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
4
Public Version Date
2024-02-15
Public Version Status
Update
Public Device Record Key
66b7f1f2-0fda-4a7b-840a-2d6b1987d863

Device Description

ECG MONITOR CABLE

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
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
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

GMDN Terms

Code Name
37423 Pin-indexed adaptor, reusable

Identifiers

Type ID
Primary 30653405015691

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K942215 000

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
10 – 90 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
10 – 32 Degrees Celsius
Type
Storage Environment Temperature
Temperature Range
50 – 90 Degrees Fahrenheit