FDA UDI
In Commercial Distribution
🇺🇸 United States
Jaeger
DI: 14250892908028
·
Model: 36-ASS1221
·
Jaeger Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Jaeger
- Primary DI
- 14250892908028
- Version / Model
- 36-ASS1221
- Catalog Number
- 36-ASS1221
- Company Name
- Jaeger Medical GmbH
- Labeler DUNS
- 329769991
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-29
- Public Version
- 1
- Public Version Date
- 2025-08-06
- Public Version Status
- New
- Public Device Record Key
- 34616853-97f0-4e71-9e62-34950d7e1177
Device Description
EXPIRATORY PRESSURE VALVE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 31318 | Airway pressure monitor, powered | A mains electricity (AC-powered) device designed to continuously measure and display the pressure values, positive and/or negative, in the upper airway (e.g., the maximal averaged inspiratory and expiratory static mouth pressure, and/or negative pressure generated by the patient during inspiration), typically in the assessment of patients with compromised pulmonary function and to determine the appropriateness of discontinuing mechanical ventilation. It typically includes a pressure indicator and a built-in alarm to signal pressure levels that exceed specific limits. It may contain batteries for independent operation when line-power is not available. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14250892908028 | GS1 |
Customer Contacts
- Phone
- +499314972127
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K940375 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius