JOJ · Class II · 21 CFR 880.2800

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
145–168 of 265
Cleared Jul 18, 2002
STEAMPLUS STERILIZATION TEST
K020409
Spsmedical Supply Corp.
General Hospital · 161d
Cleared Jul 03, 2002
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
K002741
Albert Browne , Ltd.
General Hospital · 670d
Cleared Apr 22, 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589
3M Company
General Hospital · 59d
Cleared Oct 01, 2001
BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS
K012335
Albert Browne , Ltd.
General Hospital · 69d
Cleared Mar 14, 2000
STEAM/EO RECORD CARD, MODEL CI 121
K000502
Steritec Products Mfg Co, Inc.
General Hospital · 28d
Cleared Jan 10, 2000
BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K992767
Albert Browne , Ltd.
General Hospital · 146d
Cleared Nov 23, 1999
CIDEX OPA SOLUTION TEST STRIP
K992341
Serim Research Corp.
General Hospital · 133d
Cleared Oct 08, 1999
BROWNE CIDEX OPA INDICATOR
K991709
Albert Browne , Ltd.
General Hospital · 142d
Cleared Jul 12, 1999
PASS/FAIL CHALLENGE PACK
K991276
Propper Mfg. Co., Inc.
General Hospital · 89d
Cleared Jun 10, 1999
STERI-PAK LF BOWIE-DICK TEST PACK
K990246
Steritec Products Mfg Co, Inc.
General Hospital · 135d
Cleared Jun 10, 1999
BROWNE MVI ETHYLENE OXIDE INDICATOR
K991418
Albert Browne , Ltd.
General Hospital · 48d
Cleared Apr 23, 1999
CHALLENGE TEST PACK
K983451
North American Science Assoc., Inc.
General Hospital · 205d
Cleared Feb 09, 1999
STERITITE PROCESS INDICATOR ACCESSORIES
K982151
Case Medical, Inc.
General Hospital · 236d
Cleared Feb 04, 1999
BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K984613
Albert Browne , Ltd.
General Hospital · 37d
Cleared Feb 04, 1999
BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K984616
Albert Browne , Ltd.
General Hospital · 37d
Cleared Dec 07, 1998
BROWNE GA INDICATOR FOR CIDEX PRODUCTS
K981054
Albert Browne , Ltd.
General Hospital · 259d
Cleared Nov 20, 1998
STERI-PAK BOWIE DICK TEST PACK
K982188
Steritec Products Mfg Co, Inc.
General Hospital · 151d
Cleared Nov 06, 1998
PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
K973585
Propper Mfg. Co., Inc.
General Hospital · 410d
Cleared Oct 08, 1998
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR
K982547
Steritec Products Mfg Co, Inc.
General Hospital · 79d
Cleared Jul 10, 1998
BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK
K971971
Board of Directors, Albert Browne , Ltd.
General Hospital · 407d
Cleared Jul 10, 1998
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415
Kimberly-Clark Corp.
General Hospital · 228d
Cleared Apr 23, 1998
STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM
K965212
Steritec Products Mfg Co, Inc.
General Hospital · 482d
Cleared Mar 25, 1998
CROSS-CHECKS P
K972300
Steritec Products Mfg Co, Inc.
General Hospital · 279d
Cleared Jan 29, 1998
BROWNE MVI STEAM INDICATOR
K971369
Albert Browne , Ltd.
General Hospital · 290d