Vascupuncture

GUDID 00816840020234

HERAEUS MEDICAL COMPONENTS, LLC

Peripheral vascular guidewire, manual

• Primary Device ID: 00816840020234
• NIH Device Record Key: e7f58747-ab0c-4b3b-aec5-71ac2f3162dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vascupuncture
• Version Model Number: 18045280NS
• Company DUNS: 080645456
• Company Name: HERAEUS MEDICAL COMPONENTS, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816840020234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031652

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-21

On-Brand Devices [Vascupuncture]

• 00816840020289: 18130314SW-05MPS
• 00816840020272: 18080314SW-05MPS
• 00816840020265: 18130280NW-05MPS
• 00816840020258: 18080280NW-05MPS
• 00816840020241: 18130280NW-65MPK
• 00816840020234: 18045280NS
• 00816840020180: 14080705TW
• 00816840020173: 18130360NW-55MPS
• 00816840020166: 18080360NW-55MPS
• 00816840020159: 17130314SW-05MPA
• 00816840020142: 16130613TW-05MPA
• 00816840020135: 18130280NW-03PPS
• 00816840020128: 18100280NW-03PPS
• 00816840020111: 18070280NW-03PPS
• 00816840020104: 18145280NW-03PPS
• 00816840020098: 18080280NW-03PPS
• 00816840020081: 18100280NW-05MPK
• 00816840020074: 18080280NW-05MPK
• 00816840020067: 18130360NW-65MPK
• 00816840020050: 18080360NW-65MPK
• 00816840020043: 18130364NW-65MPK
• 00816840020036: 18080364NW-65MPK
• 00816840020029: 16130334SW-65MFB
• 00816840020012: 16130345NW-05MPK
• 00816840020005: 14180278NW