ProCheck ID SM4340-1

GUDID H816MSM43402

Indicator Strips for Steam and Chemical Vapor

MicroCare, LLC

Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator

• Primary Device ID: H816MSM43402
• NIH Device Record Key: bf6cca68-2eca-4016-8bff-22f5ab64dc47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProCheck ID
• Version Model Number: SM4340
• Catalog Number: SM4340-1
• Company DUNS: 118518186
• Company Name: MicroCare, LLC
• Device Count: 250
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H816MSM43400 [Unit of Use]
HIBCC	H816MSM43401 [Primary]
HIBCC	H816MSM43402 [Package]; Contains: H816MSM43401; Package: Case Box [6 Units]; In Commercial Distribution
HIBCC	H816SM43401 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951113

FDA Product Code

• LRT: Indicator, Sterilization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-03
• Device Publish Date: 2022-10-26

Devices Manufactured by MicroCare, LLC

• H816SMQEZ22 - Spec Clean Endoscope Sponge: 2023-09-07 Enzymatic Presaturated Endoscopic Cleaning Sponge
• H816MBB0312H2 - ProBarrier: 2022-11-03 Environmental Surface Barrier, 3 x 12 instrument/equipment drape, chair sox
• H816MBB0528X2 - ProBarrier: 2022-11-03 Environmental Surface Barrier, 5 x 28 Instrument/equipment drape, x-ray sox
• H816MBB2930C2 - ProBarrier: 2022-11-03 Environmental surface barrier, 29" x 30" Instrument/equipment drape chair sox
• H816MDC0115S2 - ProBarrier: 2022-11-03 Disposable Bib Chain
• H816MPFL0082 - Shield: 2022-11-03 High-Efficiency Face Mask
• H816MPM10160 - ProView Plus: 2022-11-03 Self Sealing Sterilization Pouch, 10"x 16"https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
• H816MPM13180 - ProView Plus: 2022-11-03 Self Sealing Sterilization Pouch, 13" x 18"