FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BioVac
DI: 00816765011553
·
Model: 00711511
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioVac
- Primary DI
- 00816765011553
- Version / Model
- 00711511
- Catalog Number
- 00711511
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 5
- Public Version Date
- 2020-03-31
- Public Version Status
- Update
- Public Device Record Key
- 47932504-1ef9-49be-bd48-efb1297791ae
- Distribution End Date
- 2020-03-31
Device Description
The disposable BioVac direct suction device is indicated for transendoscopic evacuation, debulking, and/or lysing of blood, retained blood clots, or fluid, such as residual stool, within the gastrointestinal tract through the biopsy/suction channel of flexible gastrointestinal endoscopes. It also provides access for endoscopic device passage and exchange, and allows for supplemental intraprocedural irrigation when desired.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KQT | EVACUATOR, GASTRO-UROLOGY | Gastroenterology, Urology | 876.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62144 | Endoscopic suction valve, single-use, non-sterile | A non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816765011550 | GS1 | Box | 5 | Not in Commercial Distribution | 2020-03-31 |
| Primary | 00816765011553 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius