FDA.reportPublic FDA data

Anivia SG1000 Pump Console

Primary DI
00850000067110
Brand
Anivia SG1000 Pump Console
Company
APMTD, Inc.
Model
SG1000-FBS-002
Catalog number
SG1000-FBS-002
Device description
Flow Bubble Sensor
Published
2024-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWAControl, Pump Speed, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000067110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000067110008500000671108500000671100850000067110

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7816462900support_anivia@aniviamed.com

Regulatory Flags#

DUNS number
117004252
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000067141Anivia SG1000 Pump ConsoleSG1000-BBM-001SG1000-BBM-0012025-08-26
00850000067059Anivia SG1000 Pump ConsoleSG1000-DCM-001SG1000-DCM-0012024-09-11
00850000067066Anivia SG1000 Pump ConsoleSG1000-PDM-001SG1000-PDM-0012024-09-11
00850000067073Anivia SG1000 Pump ConsoleSG1000-PDM-002SG1000-PDM-0022024-09-11
00850000067080Anivia SG1000 Pump ConsoleSG1000-PDM-003SG1000-PDM-0032024-09-11
00850000067097Anivia SG1000 Pump ConsoleSG1000-PDM-004SG1000-PDM-0042024-09-11
00850000067103Anivia SG1000 Pump ConsoleSG1000-FBS-001SG1000-FBS-0012024-09-11
00850000067127Anivia SG1000 Pump ConsoleSG1000-CRT-001SG1000-CRT-0012024-09-11
00850000067134Anivia SG1000 Pump ConsoleSG1000-LSM-001SG1000-LSM-0012024-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640135140153CentriMag™Thoratec CorporationDWA2026-02-19
00850000067141Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2025-08-26
07290117830055INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830062INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830093INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830147INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830048INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
17290117830052INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830069INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830086INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
17290117830090INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830109INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830116INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
17290117830144INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
00850000067059Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067066Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067073Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067080Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067097Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067103Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067127Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
04897102200065Anivia SG1000 Pump ConsoleAsia Pacific Medical Technology Development Company LimitedDWA2024-09-11
05415067036414CentriMag™Thoratec CorporationDWA2023-05-17
00763000301347NAMEDTRONIC, INC.DWA2023-03-18
00814112020586LifeSPARCCARDIACASSIST, INC.DWA2023-02-24
00814112020906LifeSPARCCARDIACASSIST, INC.DWA2022-05-10
04033817902782CP5LivaNova Deutschland GmbHDWA2021-05-14
10860001797968OXY-1 SystemBreethe, Inc.DWA2020-12-02
00860001797961OXY-1 SystemBreethe, Inc.DWA2020-12-02
00860001797909Abiomed Breethe OXY-1 SystemBreethe, Inc.DWA2020-11-30