FDA.reportPublic FDA data

NA

Primary DI
20613994842941
Brand
NA
Company
MEDTRONIC, INC.
Model
EL404
Device description
RESERVOIR EL404 4L 40MICR CARDIOTOMY 6PK
Published
2016-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K926250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K926250000ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIRElectromedics, Inc.1993-02-19DTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994842941PackageGS16In Commercial Distribution
00613994842947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399484294120613994842941
00613994842947006139948429476139948429470613994842947

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pore Size40Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place away from extremes of temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
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
false
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
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117372446TRILLYEUROSETS SRLDTN2026-05-05
08054117372545HORIZONEUROSETS SRLDTN2026-05-05
08033178113144INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113151INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
38033178113145INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
38033178113152INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113717XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114066XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114073XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114080XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114097XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114103XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114110XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114127XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114134XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114141XTRASORIN GROUP ITALIA SRLDTN2024-12-20