FDA UDI
In Commercial Distribution
🇺🇸 United States
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
DI: 00616258021119
·
Model: SIT 96V
·
BAYER MEDICAL CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
- Primary DI
- 00616258021119
- Version / Model
- SIT 96V
- Catalog Number
- SIT 96V
- Company Name
- BAYER MEDICAL CARE INC.
- Labeler DUNS
- 058716649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-01
- Public Version
- 1
- Public Version Date
- 2019-03-04
- Public Version Status
- New
- Public Device Record Key
- 2b4e16d2-4f64-4d51-980d-82f75452ecab
Device Description
SET,PKG,SIT96V,HEREDIA,RAD,MC,LA (86105500)
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 |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00616258021119 | GS1 | ||||
| Package | 40616258021117 | GS1 | 50 | In Commercial Distribution | 9999-12-31 |
Customer Contacts
- Phone
- +1(800)633-7231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980417 | 000 |