Olympic Warm-Lamps - The Olympic Warm-Lamp Model 41/45 is a source of - NATUS MEDICAL INCORPORATED

Duns Number:962519208

Device Description: The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care env The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care environment. It provides extra warmth for Infant patients when they are 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 the user to confirm a safe minimum distance from the heat source, while the intensity control allows the user to set just the right level of radiant heat.

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More Product Details

Catalog Number

56841

Brand Name

Olympic Warm-Lamps

Version/Model Number

Model 41

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K932881

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

3029b6ff-6a2f-4ce2-8125-7d9a4741e312

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATUS MEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 302
3 A medical device with high risk that requires premarket approval 5