SJM™

Primary DI
05414734030052
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
406503
Catalog number
406503
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
15414734030059PackageGS15In Commercial Distribution
05414734030052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473403005915414734030059
05414734030052054147340300525414734030052

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
Length60Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DARK, DRY PLACE. Do not use is package is damaged.

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

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Primary DI, Brand, Company table
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00840479401072enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
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00840479401065enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401089enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
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