FDA UDI
In Commercial Distribution
🇺🇸 United States
BullDog
DI: 00816734022764
·
Model: 1203-73
·
DIVERSATEK HEALTHCARE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BullDog
- Primary DI
- 00816734022764
- Version / Model
- 1203-73
- Catalog Number
- 1203-73
- Company Name
- DIVERSATEK HEALTHCARE, INC.
- Labeler DUNS
- 030650113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-11
- Public Version
- 2
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- ecb53d8e-6c57-4666-b445-7a4b0151be46
Device Description
BullDog Disposable Endoscope Valves Set
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60760 | Endoscope channel support kit | A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816734022761 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00816734022764 | GS1 | ||||
| Package | 20816734022768 | GS1 | Box | 40 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-558-6408
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry