FDA UDI In Commercial Distribution 🇺🇸 United States

Sapphire 1100 Blower 35"

DI: 00845699000449 · Model: SFALTB · SIZEWISE RENTALS, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sapphire 1100 Blower 35"
Primary DI
00845699000449
Version / Model
SFALTB
Company Name
SIZEWISE RENTALS, L.L.C.
Labeler DUNS
967025602
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-02-05
Public Version
3
Public Version Date
2021-02-19
Public Version Status
Update
Public Device Record Key
259d5bdc-25c8-4aee-8ee2-efd6b84df28a

Device Description

120V Sapphire 1100 Blower Rev 1 and Rev 2

Device Characteristics

Single Use
No
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
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
FMR Device, Transfer, Patient, Manual

GMDN Terms

Code Name
36688 Alternating-pressure pump

Identifiers

Type ID
Primary 00845699000449