Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Surgical/medical procedure irrigation fluid FDA UDI
- Device Name
- Sterile Water FDA UDI
- Model / Reference
- 10000 FDA UDI
- Description
- Sterile Water FDA UDI
Identifiers
- Catalog Number
- 10000 FDA UDI
- Primary DI / UDI-DI
- 10884527000340 FDA UDI
- 510(k) Number
- K083042 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Surgical/medical procedure irrigation fluid FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
- Total Volume — 100 Milliliter FDA UDI
Category: Surgical/medical procedure irrigation fluid
Argyle by Cardinalhealth — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical procedure irrigation fluid.
- Pure&Clean — Pure & Clean, LLC · U
- Pure&Clean — Pure & Clean, LLC · U
- Pure&Clean — Pure & Clean, LLC · U
- Pure&Clean — Pure & Clean, LLC · U
- Pure&Clean — Pure & Clean, LLC · U
- Medline — MEDLINE INDUSTRIES, INC. · U
- Pure&Clean — Pure & Clean, LLC · U
- Medline — MEDLINE INDUSTRIES, INC. · U
Cleared under the same submission
K083042 also covers:
- Argyle — Cardinalhealth
- Argyle — Cardinalhealth
- Argyle — Cardinalhealth
- Kendall — Cardinalhealth
- Kendall — Cardinalhealth
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI c9e8e017-3bda-40e1-be58-c1478ec212b1 38 fields · synced May 30, 2026