FDA UDI In Commercial Distribution 🇺🇸 United States

Hang&Go

DI: M640R99001200041 · Model: 004 · RAND SPA
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Hang&Go
Primary DI
M640R99001200041
Version / Model
004
Catalog Number
R9900120
Company Name
RAND SPA
Labeler DUNS
655010531
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-02-12
Public Version
1
Public Version Date
2021-02-22
Public Version Status
New
Public Device Record Key
cab6c57b-4825-46f8-99e5-5290e695f74f

Device Description

Kit for Hyperthermic Perfusion

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

GMDN Terms

Code Name
47761 Intravascular/intracavitary-circulation hyperthermia system set

Identifiers

Type ID
Primary M640R99001200041

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
5 – 35 Degrees Celsius