JETWIRE 011525

GUDID 00616258005164

JETSTREAM GUIDEWIRE

Bayer Healthcare LLC

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual

• Primary Device ID: 00616258005164
• NIH Device Record Key: 89b23d71-6246-4d58-9e15-21411e4241e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JETWIRE
• Version Model Number: 011525-001
• Catalog Number: 011525
• Company DUNS: 079415061
• Company Name: Bayer Healthcare LLC
• 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: true
• 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

Device Dimensions

• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch
• Length: 0.014 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258005164 [Primary]
GS1	10616258005161 [Package]; Package: Shelf Carton [5 Units]; In Commercial Distribution

FDA Product Code

• DQX: Wire, Guide, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-02-27

Devices Manufactured by Bayer Healthcare LLC

• 00011017576983 - Dr. Scholl's: 2020-10-01 Dr. Scholl's Freeze Away Wart Remover ( blue Box) is a cryosurgical system for the removal of common and plantar warts. The dev
• 10888853003051 - Essure: 2020-04-08 Essure is a permanent Birth Control System. One Essure pouched disposable delivery system with a wound-down insert and a valved
• 20888853003058 - Essure: 2020-04-08 Essure is a permanent Birth Control System. Each Essure Kit is comprised of two pouched disposable delivery systems with a woun
• 10311017405304 - Dr. Scholl's: 2019-11-04 Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious planta
• 10016500574054 - Aleve: 2019-10-23 Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, ph
• 00325866564948 - Aleve: 2019-10-23 2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re-sealable pouch.
• 10325866565041 - Aleve: 2019-10-23 Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, ph
• 00616258005102 - POWER PULSE: 2018-08-09 PPS ANCILLARY PACK, FG PKG