Attest™ 41382F

GUDID 50707387575170

41382F RAPID 5 STM TEST PK 16EA/BX

3M COMPANY

Biological sterilization indicator

• Primary Device ID: 50707387575170
• NIH Device Record Key: 106e5816-b3b3-43e4-8a54-30262b1e69e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Attest™
• Version Model Number: 41382F
• Catalog Number: 41382F
• Company DUNS: 830016148
• Company Name: 3M COMPANY
• Device Count: 16
• 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

Customer Support Contacts

• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00707387569495 [Unit of Use]
GS1	30707387575176 [Primary]
GS1	50707387575170 [Package]; Contains: 30707387575176; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925496

FDA Product Code

• FRC: Indicator, biological sterilization process

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Attest™]

• 00707387125394: 3M™ Attest™ Monitoring Starter Kit 115
• 50707387783582: 3M™ Attest™ Auto Reader for H202 Biological Indicators 490H
• 50707387769753: 3M™ Attest™ Auto Reader for H202 Biological Indicators 490H
• 50707387767148: 390G ATTEST AUTOREADER FOR EO
• 50707387767131: 3M™ Attest™ Autoreader for Steam Model 390
• 50707387763058: 3M™ Attest™ Auto-Reader for Use with Super Rapid Readout Biological Indicators for Steam 490
• 50707387763041: 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack for 132°C 4-min and 135 degree C 3-min
• 50707387763027: 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack for 132°C 4-min and 135 degree C 3-min
• 50707387763003: 3M™ Attest™ Super Rapid Readout Steam Challenge Pack for 132°C 4-min and 135°C 3-min Steam
• 50707387762983: 3M™ Attest™ Super Rapid Readout Steam Challenge Pack for 132°C 4-min and 135°C 3-min Steam
• 50707387236477: 1296F STM PACK 5CNT/CS 25PK/CS 1CS/CTN
• 50707387236453: 1296 RAPID READOUT TEST PACK, STEAM
• 50707387222333: 3M™ Attest™ Biological Indicator Test Pack for 250°F/121°C Gravity and 270°F/132°C Vacuu
• 50707387091687: 1276 STEAM PACK 25PACKS/BX, 1BX/CS
• 50707387762969: 3M™ Attest™ Super Rapid Readout Biological Indicator for Vacuum-Assisted Steam Sterilizer Cy
• 50707387762952: 3M™ Attest™ Super Rapid Readout Biological Indicator for Gravity-Displacement Steam Steriliz
• 50707387575170: 41382F RAPID 5 STM TEST PK 16EA/BX
• 50707387569490: 41382 RAPID 5 STEAM TEST PK 16EA/BX
• 50707387470406: 1298F RAPID BI EO 25/BX 2BX/CTN
• 50707387470390: 1298 RAPID EO TEST PK25PK/BX 2BX/CS/CTN
• 50707387470383: 3M™ Attest™ Rapid Readout Biological Indicator for EO 1294
• 50707387469189: 3M™ Attest™ Steam-Plus Test Pack 41380
• 50707387236446: 3M™ Attest™ Rapid Readout Biological Indicators for 250°F/121°C Gravity and 270°F/132°C
• 50707387222340: 3M™ Attest™ Biological Indicator Test Pack for EO 1278F
• 50707387140934: 3M™ Attest™ Rapid Readout Biological Indicators for 270°F/132°C Gravity Steam Sterilizers
• 50707387091670: 1278 EO ATTEST TEST PACK
• 50707387080834: 1261P BI 25 IND/BOX 4BOX/CTN
• 50707387080827: 3M™ Attest™ Biological Indicator for 270°F/132°C Gravity Displacement Steam Sterilizers 12
• 50707387068061: 1264P "ATTEST" BIOLOGICAL ETHYLENE OXIDE INDICATOR 25 IND/BOX, 4 BOX/CTN
• 50707387068054: 3M™ Attest™ Biological Indicators for EO 1264
• 50707387043471: 3M™ Attest™ Biological Indicator for 250°F/121°C Gravity and 270°F/132°C Vacuum Assisted
• 50707387043464: 3M™ Attest™ Biological Indicator for 250°F/121°C Gravity and 270°F/132°C Vacuum Assisted
• 50605861032419: 3M™ ESPE™ Attest™ Biological Indicators for 270°F/132°C Gravity Displacement Steam Steri
• 30605861032255: 3M™ ESPE™ Attest™ Biological Indicator Incubator 116K
• 50605861026616: 3M™ Attest™ Biological Indicator for 250^F/121^C Gravity and 270^F/132^C Vacuum Assisted Ste