FDA.reportPublic FDA data

RESERVOIR

Primary DI
38033178250284
Brand
RESERVOIR
Company
SORIN GROUP ITALIA SRL
Model
D970 DIDECO AVANT R
Published
2015-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980600000D903 AVANT ADULT HOLLOW FIBER OXYGENATORDideco S.P.A.1998-08-12JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178250284PackageGS16In Commercial Distribution
08033178250283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317825028438033178250284
08033178250283080331782502838033178250283

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotomy reservoirA device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
442126587
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719893351026WellellWellell Inc.JOW2026-03-17
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25