FDA.reportPublic FDA data

Terumo® Advanced Perfusion System 1

Primary DI
00886799001394
Brand
Terumo® Advanced Perfusion System 1
Company
Terumo Cardiovascular Systems Corporation
Model
816620
Catalog number
816620
Device description
The flexible mounting arm attaches to the APS1 vertically mounting pole and is used as a mount for the centrifugal drive motor
Published
2022-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886799001394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799001394008867990013948867990013940886799001394

GMDN Terms#

Term, Definition table
TermDefinition
Portable active medical device mountA device intended to be fixed within a clinical setting (e.g., healthcare facility wall, ambulance, trolley) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
734-822-2564patricia.elka@terumomedical.com

Regulatory Flags#

DUNS number
177655466
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753537569Cardiovascular Procedure Kit787872026-07-08
00699753537576Cardiovascular Procedure Kit786052026-07-08
00699753537583Cardiovascular Procedure Kit787902026-07-08
00699753537590Cardiovascular Procedure Kit670602026-07-08
00699753537606Cardiovascular Procedure Kit787772026-07-08
00699753537613Cardiovascular Procedure KitCX-IS1292026-07-08
00699753537521Cardiovascular Procedure Kit76434-042026-06-24
00699753537538Cardiovascular Procedure Kit786942026-06-24
00699753532038Cardiovascular Procedure Kit76273-022024-07-09
00699753531956Cardiovascular Procedure Kit76873-032024-07-07
00699753512405Cardiovascular Procedure Kit75050-022020-04-23
00699753525054Cardiovascular Procedure KitCX-RU0642022-12-13
00699753537460Cardiovascular Procedure KitCX-DB080-012026-06-02
00699753537477Cardiovascular Procedure Kit787792026-06-02
00699753532731Cardiovascular Procedure Kit75959-022024-08-23
00699753532663Cardiovascular Procedure Kit73346-022024-08-20
00699753532250Cardiovascular Procedure Kit75197-012024-07-19
00699753531666Cardiovascular Procedure Kit74100-032024-06-04
00699753531345Cardiovascular Procedure Kit77087-012024-05-09
00699753531017Cardiovascular Procedure Kit65167-072024-03-21

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