Qora Collection Bag

GUDID 00860974000334

Qora Collection Bag

Consure Medical Private Limited

Faecal incontinence kit

• Primary Device ID: 00860974000334
• NIH Device Record Key: be0d5b2d-28b6-4997-ad3b-cbfce4610af3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qora Collection Bag
• Version Model Number: MG-62015-001
• Company DUNS: 650869782
• Company Name: Consure Medical Private Limited
• 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: true
• 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	00860974000334 [Primary]
GS1	10860974000331 [Package]; Package: Level 1 (10 Bags) [10 Units]; In Commercial Distribution
GS1	20860974000338 [Package]; Contains: 10860974000331; Package: Level 2(6 L-1 Boxes) [6 Units]; In Commercial Distribution
GS1	30860974000335 [Package]; Contains: 20860974000338; Package: Level 3(3 L-2 Boxes) [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153506

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-30

Devices Manufactured by Consure Medical Private Limited

• 00860974000334 - Qora Collection Bag: 2018-07-06Qora Collection Bag
• 00860974000334 - Qora Collection Bag: 2018-07-06 Qora Collection Bag
• 00860974000341 - Qora Aeon Stool Management Kit: 2018-07-06 Qora Aeon Stool Management Kit.
• 00860974000358 - Qora AIM Stool Management Kit: 2018-07-06 Qora AIM Stool Management Kit.
• 00860974000303 - Qora AIM Stool Management Kit: 2018-03-29
• 00860974000310 - Qora Aeon Stool Management Kit: 2018-03-29
• 00860974000327 - Qora Arida Stool Management Kit: 2018-03-29