FDA UDI
In Commercial Distribution
🇺🇸 United States
EM
DI: 00026072000892
·
Model: L535-011
·
Allied Medical, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- EM
- Primary DI
- 00026072000892
- Version / Model
- L535-011
- Company Name
- Allied Medical, LLC
- Labeler DUNS
- 119066872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-28
- Public Version
- 2
- Public Version Date
- 2025-10-13
- Public Version Status
- Update
- Public Device Record Key
- a00d46be-61ca-4ef3-ba72-30361b30fa87
Device Description
AUDIBLE ALARM, SPARE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35426 | Airway pressure alarm | A battery-powered warning device that monitors a patient's upper airway pressure during assisted mechanical ventilation; it typically being connected to the breathing circuit. In the event of either the pressure not rising above a minimum threshold within a maximum time span or exceeding a pre-set maximum level, the device will signal a warning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00026072000892 | GS1 |