FDA UDI
In Commercial Distribution
🇺🇸 United States
PneumoTherm
DI: 00607411006890
·
Model: 5810-0
·
SALTER LABS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PneumoTherm
- Primary DI
- 00607411006890
- Version / Model
- 5810-0
- Catalog Number
- 5810
- Company Name
- SALTER LABS
- Labeler DUNS
- 022721133
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4b04621d-ce82-4f35-9876-c49ee93e3022
Device Description
PneumoTherm™ Adaptor Cable (5810). The 5810 PneumoTherm™ Adaptor Cable is used as an interface between the 5800T and the PSG System using Din Connectors.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZQ | Monitor, breathing frequency | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35194 | Respiratory apnoea monitoring system | An assembly of devices designed to detect the cessation of breathing (apnoea) in infants and adults who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). It alarms primarily upon the cessation of breathing timed from the last detected breath, and may also include indirect methods of apnoea detection such as monitoring of heart rate and other physiological parameters associated with respiration. It may print-out this data. It will typically include a mains electricity (AC-powered) monitoring unit with software, patient leads, and possibly a recorder to record, display, or print data on a patient's breathing condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00607411006890 | GS1 |
Customer Contacts
- Phone
- +1(800)421-0024
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092685 | 000 |