FDA UDI Not in Commercial Distribution 🇺🇸 United States

SporView™ VH2O2 Self-Contained Hydrogen Peroxide Biological Indicator

DI: 10732224721504 · Model: VH50 · CROSSTEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50

Basic Information

Brand Name
SporView™ VH2O2 Self-Contained Hydrogen Peroxide Biological Indicator
Primary DI
10732224721504
Version / Model
VH50
Company Name
CROSSTEX INTERNATIONAL, INC.
Labeler DUNS
057728685
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2020-03-31
Public Version
2
Public Version Date
2023-08-25
Public Version Status
Update
Public Device Record Key
62155f87-50af-4cc4-aa3f-744bdb46ac8e
Distribution End Date
2023-08-24

Device Description

Self-Contained BI for use in monitoring VH2O2 sterilization processes

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FRC Indicator, biological sterilization process

GMDN Terms

Code Name
13732 Biological sterilization indicator

Identifiers

Type ID
Package 50732224721502
Primary 10732224721504
Unit of Use 00732224721507

Customer Contacts