FDA UDI
In Commercial Distribution
🇺🇸 United States
Argyle
DI: 10884521004009
·
Model: 8815642001
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Argyle
- Primary DI
- 10884521004009
- Version / Model
- 8815642001
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 6
- Public Version Date
- 2023-05-18
- Public Version Status
- Update
- Public Device Record Key
- c7e0794e-e912-44e4-91eb-cffc8a7af34d
Device Description
Dialysis Catheter Accessory,Dilator,10 Fr/Ch (3.3 mm), 15 cm
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 |
|---|---|---|---|---|
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | Cardiovascular | 870.1310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47085 | Peritoneal dialysis catheter, acute/chronic | A tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane, and capable of being utilized for acute and chronic peritoneal dialysis. It may be surgically or endoscopically implanted, percutaneously, for long-term use; or percutaneously inserted for one-session dialysis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521004006 | GS1 | PACK_OR_INNER_PACK | 5 | In Commercial Distribution | |
| Primary | 10884521004009 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K862288 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15 | Centimeter | |
| Catheter Gauge | 10 | French |