Spec Clean Endoscope Sponge QEZ2

GUDID H816SMQEZ22

Enzymatic Presaturated Endoscopic Cleaning Sponge

MicroCare, LLC

Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent

• Primary Device ID: H816SMQEZ22
• NIH Device Record Key: cb62f700-40ae-41b0-9f97-f0e94781404c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spec Clean Endoscope Sponge
• Version Model Number: SMQEZ2
• Catalog Number: QEZ2
• Company DUNS: 118518186
• Company Name: MicroCare, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	H816QEZ21 [Previous]
HIBCC	H816SMQEZ21 [Primary]
HIBCC	H816SMQEZ22 [Package]; Contains: H816SMQEZ21; Package: Case Box [100 Units]; In Commercial Distribution

FDA Product Code

• MNL: Accessories, Cleaning Brushes, For Endoscope

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: 2023-09-07
• Device Publish Date: 2023-08-30

Devices Manufactured by MicroCare, LLC

• H816SMQEZ22 - Spec Clean Endoscope Sponge: 2023-09-07Enzymatic Presaturated Endoscopic Cleaning Sponge
• 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"