Maximum™ 406656

GUDID 15414734015513

ST. JUDE MEDICAL, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 15414734015513
• NIH Device Record Key: a1ea60ae-b6bb-449c-bb7f-df509abcb624
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maximum™
• Version Model Number: 406656
• Catalog Number: 406656
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734015516 [Primary]
GS1	15414734015513 [Package]; Contains: 05414734015516; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870374

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-08
• Device Publish Date: 2015-04-10

On-Brand Devices [Maximum™]

• 15414734015629: HEMOSTASIS INTRODUCER
• 15414734015605: 406669
• 15414734015582: HEMOSTASIS INTRODUCER
• 15414734015568: 406665
• 15414734015544: 406660
• 15414734015520: 406657
• 15414734015513: 406656
• 15414734014998: HEMOSTASIS INTRODUCER; 8F-ACT
• 15414734014974: 406373
• 15414734014950: 406371
• 15414734014936: 406357
• 15414734014752: 406258
• 15414734014738: 406249
• 15414734010990: Xtra™
• 15414734010976: Xtra™
• 15414734010952: Xtra™
• 15414734010938: Xtra™
• 15414734010914: Xtra™
• 15414734010891: Xtra™
• 15414734010877: HEMOSTASIS INTRODUCER
• 15414734010853: Xtra™
• 15414734010839: 406667
• 15414734010815: 406363
• 15414734010792: 406361
• 15414734010778: HEMOSTASIS INTRODUCER
• 15414734010754: 406353
• 15414734010730: 406351
• 15414734009864: 406661
• 15414734009659: 406257
• 15414734009635: 406256
• 15414734008683: Xtra™
• 15414734008669: 406663
• 15414734008645: 406653
• 15414734008621: 406652
• 15414734008546: HEMOSTASIS INTRODUCER; 5F-ACT
• 15414734008522: 406359
• 15414734008508: 406347
• 15414734008485: 406259
• 15414734008423: 406255
• 15414734008409: 406253
• 15414734008386: 406252
• 15414734008362: 406251
• 15414734008348: 406250
• 05414734010993: HEMOSTASIS INTRODUCER
• 05414734010979: HEMOSTASIS INTRODUCER
• 05414734010955: HEMOSTASIS INTRODUCER
• 05414734010931: HEMOSTASIS INTRODUCER
• 05414734010917: HEMOSTASIS INTRODUCER
• 05414734010894: HEMOSTASIS INTRODUCER
• 05414734010856: HEMOSTASIS INTRODUCER