FDA UDI In Commercial Distribution 🇺🇸 United States

BASE UNIT SERVO-U

DI: 07325710001110 · Model: 6694800 · Maquet Critical Care AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BASE UNIT SERVO-U
Primary DI
07325710001110
Version / Model
6694800
Company Name
Maquet Critical Care AB
Labeler DUNS
632707092
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-01-28
Public Version
5
Public Version Date
2021-06-09
Public Version Status
Update
Public Device Record Key
4c09d224-0a5f-485a-8965-d068f7f370df

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
MR Unsafe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CBK Ventilator, Continuous, Facility Use

GMDN Terms

Code Name
42411 Neonatal/adult intensive-care ventilator

Identifiers

Type ID
Primary 07325710001110

Premarket Submissions

Submission Number Supplement Number
K151814 000
K180098 000
K201874 000