AccessGUDID - DEVICE: Olympic Warm-Lamps (00382830005470)

GUDID

Device Identifier (DI) Information

Brand Name: Olympic Warm-Lamps
Version or Model: Model 41
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 56841
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830005470
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962519208 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17433	Infant warmer	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K932881	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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