FDA.reportPublic FDA data

Olympic Warm-Lamps

Primary DI
00382830005463
Brand
Olympic Warm-Lamps
Company
NATUS MEDICAL INCORPORATED
Model
Model 31
Catalog number
56831
Device description
"""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."""
Published
2017-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932881000OLYMPIC WARM-LAMPOlympic Medical Corp.1994-01-26ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830005463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830005463003828300054633828300054630382830005463

GMDN Terms#

Term, Definition table
TermDefinition
Infant warmerA mains electricity (AC-powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-303-0306Technical.Service@natus.com

Regulatory Flags#

DUNS number
962519208
Device count
1
Serial number
true
Manufacturing date on label
true

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