FDA UDI
In Commercial Distribution
🇺🇸 United States
20” (50 cm) High Pressure Connector Tube
DI: 00616258008523
·
Model: DCT 120
·
BAYER MEDICAL CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 20” (50 cm) High Pressure Connector Tube
- Primary DI
- 00616258008523
- Version / Model
- DCT 120
- Catalog Number
- DCT 120
- Company Name
- BAYER MEDICAL CARE INC.
- Labeler DUNS
- 058716649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f43b8000-5a41-49e5-8a35-cb05a99adc9c
Device Description
20" High Pressure Connector Tube with fixed hub (TUBING, 20" CONNECTOR #82011202, MC) (85029177)
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
- Yes
- 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 |
|---|---|---|---|---|
| DWE | Tubing, Pump, Cardiopulmonary Bypass | Cardiovascular | 870.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44685 | Radiographic procedure tubing | A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40616258008521 | GS1 | 4 | In Commercial Distribution | 9999-12-31 | |
| Package | 20616258008527 | GS1 | 25 | In Commercial Distribution | 9999-12-31 | |
| Primary | 00616258008523 | GS1 |
Customer Contacts
- Phone
- +1(800)633-7231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K810924 | 000 |