Argyle
- Primary DI
- 20884521024301
- Brand
- Argyle
- Company
- Covidien LP
- Model
- 8815544003
- Catalog number
- 8815544003
- Device description
- Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,10 Fr/Ch (3.3 mm)
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
covidien.comProduct Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K871730 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20884521024301 | Package | GS1 | 5 | In Commercial Distribution |
| 10884521024304 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20884521024301 | 20884521024301 |
| 10884521024304 | 10884521024304 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 10 | French |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | ;AVOID DIRECT SUNLIGHT |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(508)261-8000 | covidien.udi@covidien.com |
Regulatory Flags#
- DUNS number
- 058614483
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10884521543799 | Signia | SIGPSHELL | 2017-08-08 | |
| 10884521856271 | Touch Surgery | MDS30001 | 2026-10-16 | |
| 10884521701243 | INVOS | PMAC71DOC | 2024-04-14 | |
| 10884521810105 | INVOS | PM7100 | 2021-06-14 | |
| 10884521780170 | INVOS | PMAC71DOC | 2019-07-31 | |
| 10884521780071 | INVOS | PM7100 | 2019-06-12 | |
| 10884521839830 | Trexon | CY904P | 2026-10-10 | |
| 10884521839861 | Trexon | CY954P | 2026-10-10 | |
| 10884521840089 | Trexon | CY811P | 2026-10-10 | |
| 10884521840126 | Trexon | CY843P | 2026-10-10 | |
| 10884521840140 | Trexon | CY883P | 2026-10-10 | |
| 10884521840171 | Trexon | CY953P | 2026-10-10 | |
| 10884521840195 | Trexon | GY123P | 2026-10-10 | |
| 10884521840249 | Trexon | GY323P | 2026-10-10 | |
| 10884521840263 | Trexon | SY823P | 2026-10-10 | |
| 10884521840270 | Trexon | SY923P | 2026-10-10 | |
| 10884521840379 | Trexon | GY122P | 2026-10-10 | |
| 10884521840409 | Trexon | GY322P | 2026-10-10 | |
| 10884521840430 | Trexon | SY5628P | 2026-10-10 | |
| 10884521840447 | Trexon | SY5638P | 2026-10-10 |
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| 00821329003462 | GORE GUIDRA Steerable Sheath | Greatbatch Ltd | DYB | 2026-10-14 |
| 00733132658855 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658862 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
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| 00733132658886 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
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| 00733132659005 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
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