Olympic Warm-Lamps 56831

GUDID 00382830005463

"The Olympic Warm-Lamp Model 31 is a source of controllable heat in the patient care environment. It provides extra warmth for infant patients when out of the bassinet for examination, bathing, weighing, feeding, or minor procedures. Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows you to confirm a safe minimum distance from the heat source, while the intensity control allows you to set just the right level of radiant heat. feeding, or minor procedures."

NATUS MEDICAL INCORPORATED

Infant warmer

• Primary Device ID: 00382830005463
• NIH Device Record Key: 11bcab82-932f-40c7-875f-b94bd9a587d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympic Warm-Lamps
• Version Model Number: Model 31
• Catalog Number: 56831
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 1-800-303-0306
• Email: Technical.Service@natus.com
• Phone: 1-800-303-0306
• Email: Technical.Service@natus.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830005463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932881

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2017-08-28

On-Brand Devices [Olympic Warm-Lamps]

• 00382830047036: The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care environme
• 00382830005470: The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care environme
• 00382830005463: "The Olympic Warm-Lamp Model 31 is a source of controllable heat in the patient care environment