Indigo System

GUDID 00814548017440

Indigo Separator 8

PENUMBRA, INC.

Thrombectomy suction catheter

• Primary Device ID: 00814548017440
• NIH Device Record Key: 2680c7f8-5291-41cf-ad1d-4a332642b042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indigo System
• Version Model Number: SEP8-A
• Company DUNS: 191077671
• Company Name: PENUMBRA, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814548017440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142870

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

[00814548017440]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-03

On-Brand Devices [Indigo System]

• 00814548017594: Separator 4
• 00814548017587: 044 Coronary Aspiration Catheter 160 cm Kit
• 00814548017556: 044 Coronary Aspiration Catheter 140 cm Kit
• 00814548017440: Indigo Separator 8
• 00814548016290: Asp Cat 8, 115cm XTORQ
• 00814548016283: Asp Cat 8, 115cm STR
• 00814548016276: Asp Cat 8, 100cm XTORQ
• 00814548016269: Asp Cat 8, 85cm STR
• 00814548016252: Asp Cat 8, 85cm TORQ
• 00814548016245: Aspiration Catheter 6
• 00814548016221: Indigo 110 Asp Tubing CE
• 00814548016214: Indigo 110 Asp Tubing
• 00814548016153: Separator 8
• 00814548016146: Separator 6
• 00814548016122: Indigo Aspiration Tubing
• 00814548016115: Separator 3
• 00814548016108: Separator 5
• 00814548016092: Asp Catheter 5, 132cm
• 00814548016085: Asp Catheter 3
• 00814548016078: Asp Catheter 4
• 00814548016061: Asp Catheter 2
• 00814548016054: Separator 2
• 00814548016047: Separator 4
• 00814548013336: Indigo Aspiration Tubing
• 00814548013329: Separator 5
• 00814548013312: Separator 3
• 00814548013305: Asp Catheter 5, 132cm
• 00814548013299: Aspiration Catheter 3
• 00815948020542: Indigo CAT 5 Kit
• 00815948020535: Asp Catheter 3 Kit
• 00815948020450: Asp Cat 8, 115cm XTORQ Kit
• 00815948020436: Asp Cat 8, 85cm STR Kit
• 00815948020412: Asp Cat 8, 85cm TORQ Kit
• 00815948020405: Aspiration Catheter 6 Kit
• 00815948020375: Indigo 110 Aspiration Tubing
• 00815948022508: Asp Cat 8, 85cm TORQ Kit
• 00815948022492: Asp Cat 8, 85cm STR Kit
• 00815948022485: Asp Cat 8, 115cm XTORQ Kit
• 00815948022478: Asp Cat 8, 115cm XTORQ
• 00815948022461: Asp Cat 8, 115cm STR
• 00815948022454: Asp Cat 8, 100cm XTORQ
• 00815948022447: Asp Cat 8, 85cm STR
• 00815948022430: Asp Cat 8, 85cm TORQ
• 00815948022546: CAT8 115 XTORQ Plus Lightning
• 00815948022539: CAT8 115 XTORQ Plus Lightning
• 00815948022324: Aspiration Catheter 8 115cm XTorq Kit
• 00815948022300: Ind Asp Cat 8, 115cm-XTORQ
• 00815948022294: Aspiration Catheter 8, 85cm TORQ Kit
• 00815948022270: Ind Asp CAT8, 85cm-TORQ
• 00815948022263: Aspiration Catheter 8, 85cm STR Kit