FDA UDI
In Commercial Distribution
🇺🇸 United States
AUTO EFFLUENT SET
DI: 07332414118914
·
Model: 115370
·
GAMBRO UF SOLUTIONS, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AUTO EFFLUENT SET
- Primary DI
- 07332414118914
- Version / Model
- 115370
- Catalog Number
- 115370
- Company Name
- GAMBRO UF SOLUTIONS, INC
- Labeler DUNS
- 132629788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-18
- Public Version
- 1
- Public Version Date
- 2025-08-26
- Public Version Status
- New
- Public Device Record Key
- a0a974c3-7548-43aa-a14e-41fdd77207dc
Device 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).
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MON | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES | Gastroenterology, Urology | 876.5820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58848 | Extracorporeal circuit waste bag | A flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit and possibly an outlet tap. The contents are considered potentially contaminated and should be disposed of according to local requirements. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 57332414118919 | GS1 | CASE | 8 | In Commercial Distribution | |
| Primary | 07332414118914 | GS1 |
Customer Contacts
- Phone
- +1(800)525-2623
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 6 | Liter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius