FDA UDI
In Commercial Distribution
🇺🇸 United States
Qora AIM Stool Management Kit
DI: 00860974000358
·
Model: MG-22014-001
·
Consure Medical Private Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Qora AIM Stool Management Kit
- Primary DI
- 00860974000358
- Version / Model
- MG-22014-001
- Company Name
- Consure Medical Private Limited
- Labeler DUNS
- 650869782
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-23
- Public Version
- 4
- Public Version Date
- 2021-01-04
- Public Version Status
- Update
- Public Device Record Key
- a6bd7aff-68a9-4c7d-855a-b287adfc7cf6
Device Description
Qora AIM Stool Management Kit.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47039 | Faecal incontinence kit | A collection of devices used for the conveyance and collection of liquid/semi-liquid stool (faeces) from the rectum to a collection bag for a patient who is unable to control stool discharge. It typically includes a balloon catheter, a disposable collection bag, a syringe, connectors, and ports for balloon inflation and irrigation. The catheter is inserted into the rectum where it is retained by the inflatable balloon for a prescribed length of time. The kit is appropriate for adult patients in an intensive care unit (ICU), other acute care settings, or for persons with a disability. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860974000358 | GS1 | ||||
| Package | 10860974000355 | GS1 | 10 Device Boxes | 10 | In Commercial Distribution | |
| Package | 20860974000352 | GS1 | 3 Shipper Boxes | 3 | In Commercial Distribution |