NEODOT

GUDID 00850024759114

Non-Contact Infrared Thermometer

Slv Pharmaceuticals LLC

Infrared patient thermometer, skin

• Primary Device ID: 00850024759114
• NIH Device Record Key: a7dc56b6-50e9-40a0-85f9-584db257acb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEODOT
• Version Model Number: CK-T1502
• Company DUNS: 081225162
• Company Name: Slv Pharmaceuticals LLC
• Device Count: 1
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850024759114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193253

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: 2
• Public Version Date: 2020-12-04
• Device Publish Date: 2020-11-16

Devices Manufactured by Slv Pharmaceuticals LLC

• 00373317464712 - BREATH COMFORT: 2022-03-16 BREATH COMFORT HUMIDIFIER
• 00373317495211 - BREATHE COMFORT: 2022-03-16 BREATHE COMFORT OPTICHAMBERS - MEDIUM CHILD
• 00373317495228 - BREATHE COMFORT: 2022-03-16 BREATHE COMFORT OPTICHAMBERS - ADULT
• 00373317568212 - AUM: 2022-03-16 AUM MOISTURIZING GEL SOCKS
• 00373317000064 - AUM: 2022-03-16 AUM SAFETY PEN NEEDLES 32G -4MM
• 00373317000033 - AUM: 2022-03-16 AUM MINI PEN NEEDLES 31G - 4MM
• 00373317000026 - AUM: 2022-03-16 AUM MINI PEN NEEDLES 31G - 5MM
• 00373317000057 - AUM: 2022-03-16 AUM MINI PEN NEEDLES 31G - 6MM