Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Peritoneal dialysis catheter, chronic FDA UDI
- Device Name
- Peritoneal Dialysis Catheter,Moncrief-Popovich Swan Neck Curl Cath, 2 Cuff,62.5 cm FDA UDI
- Model / Reference
- 8888414029 FDA UDI
- Description
- Peritoneal Dialysis Catheter,Moncrief-Popovich Swan Neck Curl Cath, 2 Cuff,62.5 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521004672 FDA UDI
- 510(k) Number
- K862046 FDA UDI
- FDA Product Code
- FJS FDA UDI
- GMDN Term
- Peritoneal dialysis catheter, chronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 62.5 Centimeter FDA UDI
Category: Peritoneal dialysis catheter, chronic
Argyle by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis catheter, chronic.
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Cook — COOK INCORPORATED · Class I
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Lifemed Chronic Tenckhoff Peritoneal Catheter — Lifemed of California · Class II
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Cook — COOK INCORPORATED · Class I
- Cook — COOK INCORPORATED · Class I
Cleared under the same submission
K862046 also covers:
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
- Argyle — Mozarc Medical US LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mozarc Medical US LLC
Sources (1)
- FDA UDI dc6e710a-2ac1-412d-a0f4-b98bc9fbf386 36 fields · synced Jun 8, 2026