FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160
DI: 00884838101449
·
Model: Pneumatic Respiration Chest Bellows
·
Philips Ds North America LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160
- Primary DI
- 00884838101449
- Version / Model
- Pneumatic Respiration Chest Bellows
- Catalog Number
- 94023
- Company Name
- Philips Ds North America LLC
- Labeler DUNS
- 013649151
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-06
- Public Version
- 6
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 857fbd6e-9054-4a78-8f25-f5260d18124f
- Distribution End Date
- 2023-06-01
Device Description
PNEUMOGRAPH,CHEST,NM,3160
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35244 | Pneumograph | A device designed to graphically display chest movement during the respiratory cycle. It uses a sensor, e.g. Electrical impedance, to detect and transduce respiratory chest movement and may display both the rate and waveform of the movement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838101449 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 80 Percent (%) Relative Humidity