SJM™

Primary DI
05415067009470
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
406502
Catalog number
406502
Device description
REPOSITIONING SLEEVE
Published
2016-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQRCANNULA, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQRCannula, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884478000DAIG COLLAPSIBLE STERILE SLEEVEDaig Corp.1989-02-22DQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15415067009477PackageGS15In Commercial Distribution
05415067009470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541506700947715415067009477
05415067009470054150670094705415067009470

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery catheter sheathA noninvasive, flexible sleeve intended to be used during pulmonary artery catheterization to cover and protect the exposed proximal end of a pulmonary artery catheter to prevent contamination (extending the sterile field of the external catheter) and/or to contain a backflow of blood (e.g., during catheter introduction, repositioning or removal). It is typically transparent, made of synthetic polymers, and includes appropriate connectors for distal attachment to the catheter introducer, and proximal attachment to the extracorporeal portion of the catheter. Neither the catheter nor introduction/procedural devices are included (i.e., not a set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL,DARK,DRY PLACE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479400167enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401034enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401058enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401072enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479400174enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401041enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401065enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401089enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
05415067042835NAST. JUDE MEDICAL, INC.DQR2022-02-16
H787065068010Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065068020Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065068030Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065068040Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065068050Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072010Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072020Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072030Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072040Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072100MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065072110MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065072120MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065072130MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065076010EmbosafeANGIODYNAMICS, INC.DQR2016-09-20
H787065076020EmbosafeANGIODYNAMICS, INC.DQR2016-09-20
H787065076030EmbosafeANGIODYNAMICS, INC.DQR2016-09-20
H787065084020MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065084030MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065084040MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065086010Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065086020Micro AccessANGIODYNAMICS, INC.DQR2016-09-20