FDA UDI
In Commercial Distribution
🇺🇸 United States
Coeur
DI: M297722010
·
Model: C853-2201
·
COEUR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Coeur
- Primary DI
- M297722010
- Version / Model
- C853-2201
- Catalog Number
- C853-2201
- Company Name
- COEUR, INC.
- Labeler DUNS
- 132515441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-11
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 5e30f73b-a66c-445f-961f-07fc08d01947
Device Description
MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1-115mL Syringe, 1-96" Y-Line, and 2 Spikes)
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15286 | Angiographic syringe | A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M297722016 | HIBCC | shipper | 50 | In Commercial Distribution | |
| Primary | M297722010 | HIBCC |
Customer Contacts
- Phone
- 1-800-296-5893
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161471 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 115 | Milliliter | |
| Total Volume | 65 | Milliliter | |
| Length | 96 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature.