Heating tube set for insufflation, single use

GUDID 04056702008789

W.O.M. World of Medicine GmbH

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 04056702008789
• NIH Device Record Key: 8f7705d6-93ee-4598-9f66-08c492c33cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heating tube set for insufflation, single use
• Version Model Number: INSFHTDTUB
• Company DUNS: 316305242
• Company Name: W.O.M. World of Medicine GmbH
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056702008772 [Primary]
GS1	04056702008789 [Package]; Contains: 04056702008772; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153513

FDA Product Code

• HIF: Insufflator, Laparoscopic

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: 2020-11-09
• Device Publish Date: 2020-11-01

On-Brand Devices [Heating tube set for insufflation, single use]

• 04056702002831: Z0260
• 04056702007379: Z0260
• 04056702008789: INSFHTDTUB