FDA UDI In Commercial Distribution 🇺🇸 United States

Portrait™ AirShuttle™

DI: 10841962111253 · Model: RT-5100-02 · Qfix
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Portrait™ AirShuttle™
Primary DI
10841962111253
Version / Model
RT-5100-02
Catalog Number
RT-5100-02
Company Name
Qfix
Labeler DUNS
808875397
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-28
Public Version
3
Public Version Date
2023-12-11
Public Version Status
Update
Public Device Record Key
02695a53-b3c9-4bca-a8cf-879ed4da54f6

Device Description

Portrait™ AirShuttle™

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 Safe
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
LHN System, radiation therapy, charged-particle, medical
OUO Tomographic imager combining emission computed tomography with nuclear magnetic resonance
LNH System, nuclear magnetic resonance imaging
KPS System, tomography, computed, emission
JAI Couch, radiation therapy, powered
FRZ DEVICE, PATIENT TRANSFER, POWERED
JAK System, x-ray, tomography, computed
IYE Accelerator, linear, medical

GMDN Terms

Code Name
40536 Patient lifting system stretcher

Identifiers

Type ID
Primary 10841962111253

Customer Contacts

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
10 – 40 Degrees Celsius
Type
Storage Environment Atmospheric Pressure
Temperature Range
70 – 106 KiloPascal
Type
Storage Environment Temperature
Temperature Range
0 – 50 Degrees Celsius
Type
Handling Environment Atmospheric Pressure
Temperature Range
70 – 106 KiloPascal
Type
Handling Environment Humidity
Temperature Range
10 – 90 Percent (%) Relative Humidity
Type
Storage Environment Humidity
Temperature Range
0 – 95 Percent (%) Relative Humidity