Qora Collection Bag

GUDID 00860974000334

Qora Collection Bag

Consure Medical Private Limited

Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit 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