FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Pressure ManometerSingle Patient Use
DI: 05707480032372
·
Model: 322004000
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable Pressure ManometerSingle Patient Use
- Primary DI
- 05707480032372
- Version / Model
- 322004000
- Catalog Number
- 322004000
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- 1d2f6b3d-710c-4930-8937-6a60b6b8258e
- Distribution End Date
- 2026-05-27
Device Description
Manometer - 20PCS/BOX, 12BOXES/T30BOX US
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | Anesthesiology | 868.2600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46634 | Airway pressure monitor, non-powered | A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480036233 | GS1 | 12 | In Commercial Distribution | 2026-05-27 | |
| Package | 05707480020782 | GS1 | 20 | In Commercial Distribution | 2026-05-27 | |
| Primary | 05707480032372 | GS1 |
Customer Contacts
- Phone
- +1(410)768-6464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 6.4 | Gram | |
| Length | 55 | Millimeter | |
| Outer Diameter | 22 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 50 Degrees Celsius