FDA UDI Not in Commercial Distribution 🇺🇸 United States

Aquamantys®3

DI: 00643169078369 · Model: 40-404-1 · MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Aquamantys®3
Primary DI
00643169078369
Version / Model
40-404-1
Company Name
MEDTRONIC, INC.
Labeler DUNS
030200852
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-16
Public Version
4
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
daa928dc-983c-453a-a850-5bc088fee481
Distribution End Date
2017-08-17

Device Description

GENERATOR 40-404-1 AQM3

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
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
11490 Electrosurgical system generator

Identifiers

Type ID
Primary 00643169078369

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-4 – 149 Degrees Fahrenheit
Type
Storage Environment Humidity
Temperature Range
20 – 85 Percent (%) Relative Humidity