Identity
- Trade Name
- AUTO EFFLUENT SET FDA UDI
- Generic Name
- Extracorporeal circuit waste bag FDA UDI
- Device Name
- The Auto Effluent Accessory is indicated for use only with the PrisMax control unit in providing automatic effluent draining during Continuous Renal Replacement Therapy (CRRT). FDA UDI
- Model / Reference
- 115370 FDA UDI
- Description
- The Auto Effluent Accessory is indicated for use only with the PrisMax control unit in providing automatic effluent draining during Continuous Renal Replacement Therapy (CRRT). FDA UDI
Identifiers
- Catalog Number
- 115370 FDA UDI
- Primary DI / UDI-DI
- 07332414118914 FDA UDI
- FDA Product Code
- MON FDA UDI
- GMDN Term
- Extracorporeal circuit waste bag FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5820 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 6 Liter FDA UDI
Category: Extracorporeal circuit waste bag
Auto Effluent Set by Gambro UF Solutions LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal circuit waste bag.
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- Easy Catcher — Advance Medical Designs, Inc. · Class II
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- Easy Catcher — Advance Medical Designs, Inc. · Class II
- Medex — ICU MEDICAL, INC. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gambro UF Solutions LLC
Sources (1)
- FDA UDI a0a974c3-7548-43aa-a14e-41fdd77207dc 37 fields · synced Jun 9, 2026