Qora AIM Stool Management Kit

GUDID 00860974000358

Qora AIM Stool Management Kit.

Consure Medical Private Limited

Faecal incontinence kit

• Primary Device ID: 00860974000358
• NIH Device Record Key: a6bd7aff-68a9-4c7d-855a-b287adfc7cf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qora AIM Stool Management Kit
• Version Model Number: MG-22014-001
• Company DUNS: 650869782
• Company Name: Consure Medical Private Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00860974000358 [Primary]
GS1	10860974000355 [Package]; Package: 10 Device Boxes [10 Units]; In Commercial Distribution
GS1	20860974000352 [Package]; Contains: 10860974000355; Package: 3 Shipper 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: 2017-11-23

On-Brand Devices [Qora AIM Stool Management Kit]

• 00860974000358: Qora AIM Stool Management Kit.
• 00860974000303: MG-01975-002