CLS

GUDID 20864039000400

Insufflation Tubing Set

COASTAL LIFE SYSTEMS, INC.

Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use

• Primary Device ID: 20864039000400
• NIH Device Record Key: 25162b89-3f38-4d88-ac48-412f2dcc5fd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLS
• Version Model Number: CT1001
• Company DUNS: 610391229
• Company Name: COASTAL LIFE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864039000406 [Primary]
GS1	10864039000403 [Package]; Contains: 00864039000406; Package: [10 Units]; In Commercial Distribution
GS1	20864039000400 [Package]; Contains: 10864039000403; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• NKC: Tubing/Tubing With Filter, Insufflation, Laparoscopic

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: 2017-12-05

On-Brand Devices [CLS]

• 10864039000410: Saphenous Vein Cannula
• 20864039000400: Insufflation Tubing Set