FDA Product Code JOJ: Indicator, Physical/chemical Sterilization Process
FDA product code JOJ covers physical and chemical sterilization process indicators.
These indicators use temperature-sensitive inks, chemical reactions, or physical changes to confirm that instruments have been exposed to sterilization conditions. They provide a visual, immediate confirmation that packages have passed through the sterilization cycle, distinguishing processed from unprocessed items.
JOJ devices are Class II medical devices, regulated under 21 CFR 880.2800 and reviewed by the FDA General Hospital panel.
Leading manufacturers include STERIS Corporation, 3M Company and Spsmedical Supply Corp..
265
Total
264
Cleared
152d
Avg days
1976
Since
265 devices
Cleared
Jul 11, 2008
SERIM DISINTEK OPA TEST STRIP
Serim Research Corp.
General Hospital
57d
Cleared
Jun 11, 2008
BROWNE OPA TEST STRIP
STERIS Corporation
General Hospital
21d
Cleared
May 12, 2008
BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR
STERIS Corporation
General Hospital
56d
Cleared
Apr 30, 2008
EMU-GRAPH EMULATOR, MODEL CI 131
Steritec Products Mfg Co, Inc.
General Hospital
247d
Cleared
Jan 25, 2008
VERIFY CHALLENGE PACKS - VERSION 2
STERIS Corporation
General Hospital
28d
Cleared
Dec 11, 2007
VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2
STERIS Corporation
General Hospital
96d
Cleared
Nov 14, 2007
VERIFY 275 DEGREE F. 3-10 INDICATOR
STERIS Corporation
General Hospital
128d
Cleared
Sep 05, 2007
VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK
STERIS Corporation
General Hospital
159d
Cleared
Jul 17, 2007
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
STERIS Corporation
General Hospital
151d
Cleared
Jan 12, 2007
RELIANCE CI PROCESS INDICATOR
Albert Browne , Ltd.
General Hospital
73d
Cleared
Jan 05, 2007
STEAMPLUS STEAM INTEGRATOR
Spsmedical Supply Corp.
General Hospital
14d
Cleared
Aug 25, 2006
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
Albert Browne , Ltd.
General Hospital
66d
Cleared
Jul 18, 2006
VERIFY DRY HEAT LABEL
Albert Browne , Ltd.
General Hospital
216d
Cleared
Mar 24, 2006
VERIFY 3-10 MIN FLASH INTEGRATOR
Albert Browne , Ltd.
General Hospital
74d
Cleared
Mar 07, 2006
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
Albert Browne , Ltd.
General Hospital
53d
Cleared
Dec 06, 2005
VERIFY FLASH INTEGRATOR
Albert Browne , Ltd.
General Hospital
221d
Cleared
Dec 01, 2005
SERIM PERACETIC ACID CHEMICAL INDICATOR
Serim Research Corp.
General Hospital
92d
Cleared
Dec 21, 2004
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
STERIS Corporation
General Hospital
4d
Cleared
Aug 17, 2004
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
Propper Mfg. Co., Inc.
General Hospital
494d
Cleared
Jun 25, 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
Spsmedical Supply Corp.
General Hospital
66d
Cleared
Apr 02, 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
Advanced Sterilization Products
General Hospital
10d
Cleared
Oct 17, 2003
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
Albert Browne , Ltd.
General Hospital
38d
Cleared
May 09, 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
Spsmedical Supply Corp.
General Hospital
65d
Cleared
Oct 08, 2002
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
Advanced Sterilization Products
General Hospital
75d