Chemical/physical sterilization process indicator - India CDSCO Medical Device Registration

Chemical/physical sterilization process indicator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000524_d9d916048e6d1f8dbef6840000807824_634c8a4db1db6f29d1aceaade8362295. This device is marketed under the brand name 3M Comply Bowie-Dick Plus Test Pack. The license holder is 3M India Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Chemical/physical sterilization process indicator

UID: IMP/MD/2022/000524_d9d916048e6d1f8dbef6840000807824_634c8a4db1db6f29d1aceaade8362295

Brand Name

3M Comply Bowie-Dick Plus Test Pack

License Holder

3M India Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Use the 3M Comply Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the STERRAD 100, STERRAD 100S, STERRAD NX (3M Comply Bowie-Dick Plus Test Pack), STERRAD 100NX (3M Comply Bowie-Dick Plus Test Pack), STERRAD NX with ALLClear Technology (3M Comply Bowie-Dick Plus Test Pack), STERRAD 100NX with ALLClear Technology (3M Comply Bowie-Dick Plus Test Pack), AMSCO V-PRO 1 (3M Comply Bowie-Dick Plus Test Pack), AMSCO V-PRO 1 Plus (3M Comply Bowie-Dick Plus Test Pack), AMSCO V-PRO max Low Temperature Sterilization System (3M Comply Bowie-Dick Plus Test Pack) Sterilizers. The chemical indicator bar turns from blue towards pink after exposure to vaporized hydrogen peroxide