Cool-Cap

Primary DI
00382830009584
Brand
Cool-Cap
Company
NATUS MEDICAL INCORPORATED
Model
60027
Catalog number
60027
Device description
COOLING CAP SET, LARGE SIZE, INT
Published
2014-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MXMCap,Cooling (Infants)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXMCap, Cooling (Infants)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040025000OLYMPIC COOL-CAPNatus Medical Incorporated2006-12-20MXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830009584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830009584003828300095843828300095840382830009584

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid whole-body cooling system control unitA mains electricity (AC-powered) device intended to be used as part of a circulating-fluid whole-body cooling system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), for cooling a patient’s whole-body (i.e., lower core body temperature). The device includes a refrigeration unit, a pump, and typically a fluid reservoir; it may also be intended for patient temperature monitoring. It is intended to be used by a healthcare professional in a clinical setting typically to treat patients who are hyperthermic/feverish or to induce hypothermia for metabolism reduction (e.g., during surgery).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962519208
Device count
1
No natural rubber latex
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382830004169Cool-CapNATUS MEDICAL INCORPORATEDMXM2014-09-16
00382830009577Cool-CapNATUS MEDICAL INCORPORATEDMXM2014-09-15
00382830016308Cool-CapNATUS MEDICAL INCORPORATEDMXM2014-09-15
00382830009560Cool-CapNATUS MEDICAL INCORPORATEDMXM2014-09-10