FDA UDI In Commercial Distribution 🇺🇸 United States

Patient Circuit

DI: 17290013641882 · Model: V64-0069 · FLIGHT MEDICAL INNOVATIONS LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Patient Circuit
Primary DI
17290013641882
Version / Model
V64-0069
Company Name
FLIGHT MEDICAL INNOVATIONS LTD
Labeler DUNS
600023576
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-09-29
Public Version
5
Public Version Date
2022-10-24
Public Version Status
Update
Public Device Record Key
4e16c089-710c-47cc-b7f2-1b32ce620889

Device Description

F60 SL Ped SU PC RD

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NOU Continuous, Ventilator, Home Use
CBK Ventilator, Continuous, Facility Use

GMDN Terms

Code Name
37706 Ventilator breathing circuit, single-use

Identifiers

Type ID
Primary 17290013641882

Premarket Submissions

Submission Number Supplement Number
K120726 000