FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Atmos
DI: E261UDAELN0
·
Model: UD-AELN
·
BIOENGINEERING LABORATORIES SRL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Atmos
- Primary DI
- E261UDAELN0
- Version / Model
- UD-AELN
- Company Name
- BIOENGINEERING LABORATORIES SRL
- Labeler DUNS
- 447644969
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-03
- Public Version
- 2
- Public Version Date
- 2025-09-03
- Public Version Status
- Update
- Public Device Record Key
- a77a6c49-2601-474a-88ac-970e540f9c51
- Distribution End Date
- 2025-05-01
Device Description
Transparent extension line 1500mm
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 |
|---|---|---|---|---|
| 44675 | Urological pressure monitoring tubing set | A collection of devices that includes the tubing and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used as an external connection for the invasive measurement of urethral and related urological pressures. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | E261UDAELN1 | HIBCC | Shelf Box | 50 | Not in Commercial Distribution | 2025-05-01 |
| Primary | E261UDAELN0 | HIBCC | ||||
| Package | E261UDAELN2 | HIBCC | Shipping Carton | 2 | Not in Commercial Distribution | 2025-05-01 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1500 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius