FDA.reportPublic FDA data

Olympic Vac-Pac

Primary DI
00382830005395
Brand
Olympic Vac-Pac
Company
NATUS MEDICAL INCORPORATED
Model
Size 30
Catalog number
51630
Device description
Olympic Vac-Pac Size 30
Published
2020-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830005395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830005395003828300053953828300053950382830005395

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning vacuum mattressA device designed to position and immobilize a patient's full-body typically during therapeutic interventions or patient transportation. The device immobilizes the body by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the body that it encompasses until the vacuum is released.

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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00382830045315Echo-Screen III ProEchoScreen III Refurbished, TEOAE & DPOAE with bar023483R2020-02-20
00382830045339Echo-Screen III ProEchoScreen III Refurbished, TEOAE & ABR with barco023484R2020-02-20
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