FDA UDI
In Commercial Distribution
🇺🇸 United States
Ostoh
DI: 00860010269800
·
Model: OSV001
·
Ostoh, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Ostoh
- Primary DI
- 00860010269800
- Version / Model
- OSV001
- Catalog Number
- OSV001
- Company Name
- Ostoh, LLC
- Labeler DUNS
- 047557321
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-16
- Public Version
- 1
- Public Version Date
- 2024-12-24
- Public Version Status
- New
- Public Device Record Key
- e47895da-712b-4b3b-9f4d-c97b3716fee5
Device Description
Ostomy valve appliance to aid in the venting of gas from within the ostomy bag.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| EZS | Appliance, Colostomy, Disposable | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65720 | Ostomy bag pressure release valve | A plug-like device intended to be attached to an ostomy bag at a bag penetration site to facilitate the release of gas pressure within the bag for the prevention of unwanted inflation. It is typically in the form of single-piece adhesive ring and removable stopper. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010269800 | GS1 |