FDA UDI
In Commercial Distribution
🇺🇸 United States
Coeur Acist
DI: M297620420
·
Model: C465-2042
·
COEUR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Coeur Acist
- Primary DI
- M297620420
- Version / Model
- C465-2042
- Catalog Number
- C465-2042
- Company Name
- COEUR, INC.
- Labeler DUNS
- 132515441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-14
- Public Version
- 3
- Public Version Date
- 2019-02-04
- Public Version Status
- Update
- Public Device Record Key
- aa6a31cc-cede-4e7d-8968-fd029729e515
Device Description
Empower CTA Connecting Tube
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 |
|---|---|---|---|---|
| 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 | M297620425 | HIBCC | case | 50 | In Commercial Distribution | |
| Primary | M297620420 | HIBCC | ||||
| Package | M297620426 | HIBCC | shipper | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-296-5893
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942381 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep product in clean, dry location. Avoid direct rays, heat and high humidity, and ultraviolet rays such as a germicidal light.