FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Atmos
DI: E261UDA362050
·
Model: UD-A36205
·
BIOENGINEERING LABORATORIES SRL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Atmos
- Primary DI
- E261UDA362050
- Version / Model
- UD-A36205
- Company Name
- BIOENGINEERING LABORATORIES SRL
- Labeler DUNS
- 447644969
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-02
- Public Version
- 2
- Public Version Date
- 2025-09-02
- Public Version Status
- Update
- Public Device Record Key
- 63486df9-e3ef-4f9c-805e-3ffe06f6ddf1
- Distribution End Date
- 2025-05-01
Device Description
Pump Tubing 3,2 x 6,4
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 |
|---|---|---|---|---|
| EXQ | Cystometer, Electrical Recording | Gastroenterology, Urology | 876.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14301 | Urological irrigation set | A collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | E261UDA362051 | HIBCC | Shelf box | 25 | Not in Commercial Distribution | 2025-05-01 |
| Primary | E261UDA362050 | HIBCC | ||||
| Package | E261UDA362052 | HIBCC | Shipping carton | 2 | Not in Commercial Distribution | 2025-05-01 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 6.4 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius