HCS

GUDID 10849027002560

Digital Thermometer-Rectal

DYAD MEDICAL SOURCING, LLC

Continuous electronic patient thermometer, battery-powered

• Primary Device ID: 10849027002560
• NIH Device Record Key: 242335cd-e5ca-4a23-af79-48387b8d6f6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HCS
• Version Model Number: HCS9004
• Company DUNS: 078572603
• Company Name: DYAD MEDICAL SOURCING, LLC
• Device Count: 25
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849027002563 [Primary]
GS1	10849027002560 [Package]; Contains: 00849027002563; Package: Case [500 Units]; In Commercial Distribution
GS1	84902700256300 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041516

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2017-01-13

On-Brand Devices [HCS]

• 10849027004489: IV Start Kit
• 10849027004472: Laceration Kit
• 10849027004465: IV Start Kit
• 10849027004410: Biopsy Tray
• 10849027004397: CVP Dressing Kit
• 10849027004311: Infusion Stop Kit
• 10849027004021: Suture Removal Kit
• 10849027003901: Central Line Dressing
• 10849027003895: HCS0008C
• 10849027003680: Sterilization Pouch 12" x 17"
• 10849027003673: Sterilization Pouch 9" x 15"
• 10849027003666: Sterilization Pouch 7.5" x 13"
• 10849027003659: Sterilization Pouch 5.25" x 10"
• 00849027003645: Sterilization Pouch 3.5" x 9"
• 10849027003437: Digital Thermometer
• 10849027003246: Staple Remover Kit
• 10849027003093: Dressing Change Kit
• 10849027002874: Inflation System, Child
• 10849027002867: Inflation System, Large Adult
• 10849027002850: Inflation System, Adult
• 00849027002839: Pain Management Kit
• 10849027002676: Electrode
• 10849027002669: HCS9101-50
• 00849027002655: Electrode
• 10849027002645: Electrode
• 10849027002638: Electrode
• 00849027002600: IV Start Kit
• 10849027002591: Central Line Dressing Kit
• 10849027002584: HCS5006C
• 10849027002577: IV Start Kit
• 10849027002560: Digital Thermometer-Rectal
• 10849027002553: Probe Covers
• 10849027002546: Digital Thermometer
• 10849027002522: Digital Thermometer Flex Tip
• 10849027002508: IV Start Kit
• 10849027002485: IV Start Kit
• 10849027002393: Biopsy Tray
• 10849027002379: Laceration Kit
• 10849027002348: Single Patient Use Sphygmomanometer, Latex Free, Large Adult
• 10849027002331: Single Patient Use Sphygmomanometer, Latex Free, Adult
• 10849027002324: Single Patient Use Sphygmomanometer, Latex Free, Child
• 10849027002256: OR Towel 17" x 26"
• 10849027002249: OR Towel 17" x 26"
• 10849027002232: OR Towel 17" x 26"
• 00849027002228: OR Towel 17" x 26"- Non-sterile
• 10849027002218: OR Towel 17" x 26"
• 10849027002201: OR Towel 17" x 26"
• 10849027002195: OR Towel 17" x 26"
• 10849027002171: PICC Line Advanced Dressing Kit
• 10849027001334: Suture Removal Kit