SJM™

Primary DI
15414734026502
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
406500
Catalog number
406500
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
OTC
false
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
15414734026502PackageGS15In Commercial Distribution
05414734026505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473402650215414734026502
05414734026505054147340265055414734026505

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead/sensor/probe cover, sterileA sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. 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
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
true
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
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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