JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW 5855-240-32

GUDID 06934955932786

Percutaneous Transluminal Angioplasty Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06934955932786
• NIH Device Record Key: c71c7f1a-2b3a-4c96-84ad-463181af3eb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
• Version Model Number: 5855-240-32
• Catalog Number: 5855-240-32
• Company DUNS: 530923226
• Company Name: OrbusNeich Medical (ShenZhen) Co., Ltd.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955932786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241025

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-20

On-Brand Devices [JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW]

• 06934955930911: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930904: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930898: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930881: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930874: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930867: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930850: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930843: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930836: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930829: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930812: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930805: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930799: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930782: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930775: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930768: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930751: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930744: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930737: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930720: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930713: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930706: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930690: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930683: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930676: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930669: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930652: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930645: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930638: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930621: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930614: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930607: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930591: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930584: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930577: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930560: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930553: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930546: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930539: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930522: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930515: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930508: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930492: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930485: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930478: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930461: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930454: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930447: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930430: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955930423: Percutaneous Transluminal Angioplasty Balloon Catheter