FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HEARTLINE FLUSHING ADAPTER
DI: B09928000050
·
Model: 2800-005
·
SONTEC INSTRUMENTS, INC.
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
- HEARTLINE FLUSHING ADAPTER
- Primary DI
- B09928000050
- Version / Model
- 2800-005
- Catalog Number
- 2800-005
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-14
- Public Version
- 6
- Public Version Date
- 2024-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2f193177-c184-4d15-87ad-97c981e0feb0
- Distribution End Date
- 2018-09-22
Device Description
HEARTLINE FLUSHING ADAPTER (LUER)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65551 | Endoscope flushing adaptor, reusable | A small attachment designed to be fitted to an endoscope port for flushing of the endoscope’s lumen(s) during post-procedural washing, disinfection and/or sterilization. It is in the form of a plug that may include a button/switch for control of fluid (e.g., sterilant, disinfectant) and/or air through the lumen; it does not include tubing (i.e., not a tubing set). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B09928000050 | HIBCC |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152400 | 000 |