1017960 HealthFirst Mail-In Spore Testing Service, 12 Test HF-Y12

GUDID M985HFY120

Private label MIST product

MESA LABORATORIES, INC.

Biological sterilization indicator

• Primary Device ID: M985HFY120
• NIH Device Record Key: be6f5e2b-5764-42d8-98d6-458b31cb0103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1017960 HealthFirst Mail-In Spore Testing Service, 12 Test
• Version Model Number: HF-Y12
• Catalog Number: HF-Y12
• Company DUNS: 102530326
• Company Name: MESA LABORATORIES, INC.
• Device Count: 12
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M985HFY12 [Unit of Use]
HIBCC	M985HFY120 [Primary]

FDA Product Code

• FRC: Indicator, Biological Sterilization Process

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: 2024-12-26
• Device Publish Date: 2024-12-18

Devices Manufactured by MESA LABORATORIES, INC.

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• M9850161000 - Spore Strip - EO/Dry Heat: 2025-01-23 Mesa Labs atrophaeus spore strip for ethylene oxide/dry heat. 10e6. 100 count package.
• M9850341000 - Spore Strip: 2025-01-23 Mesa Labs steam spore strip. 10e4 population. 100 count package.
• M9850351000 - Spore Strip Steam & Chemiclave: 2025-01-23 Mesa Labs steam spore strip 10e5 population. 100 count package
• M9850361000 - Spore Strip Steam & Chemiclave: 2025-01-23 Mesa Labs steam spore strips-10e6 population 100 count package
• M985051000C0 - Dual Spore Strips - Control: 2025-01-23 Mesa Labs dual species spore strip controls. 10e5/10e6 population. 1000 count package.
• M985051000T0 - Dual Spore Strips - Test: 2025-01-23 Mesa Labs dual species spore strips. 10e5/10e6 population. 1000 count package.
• M985HFY120 - 1017960 HealthFirst Mail-In Spore Testing Service, 12 Test: 2024-12-26Private label MIST product
• M985HFY120 - 1017960 HealthFirst Mail-In Spore Testing Service, 12 Test: 2024-12-26 Private label MIST product