FDA UDI
In Commercial Distribution
🇺🇸 United States
ExSpiron Pediatric PadSets
DI: 00851540007161
·
Model: Pediatric
·
Senzime AB (Publ.)
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ExSpiron Pediatric PadSets
- Primary DI
- 00851540007161
- Version / Model
- Pediatric
- Catalog Number
- RMI-53040
- Company Name
- Senzime AB (Publ.)
- Labeler DUNS
- 559976316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-25
- Public Version
- 1
- Public Version Date
- 2024-02-02
- Public Version Status
- New
- Public Device Record Key
- e4d64e42-c0d8-4e62-b964-5242de6c41be
Device Description
A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | Anesthesiology | 868.2375 | 2 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | Anesthesiology | 868.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35353 | Monitoring spirometer, electrical | A mains electricity (AC-powered) device designed to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. It may also be used to measure the tidal volume, minute volume, and respiration rate delivered to a patient via the expiratory ports of resuscitation devices, such as transport ventilators and resuscitators, to evaluate their performance. The device may incorporate high and low tidal volume alarms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851540007161 | GS1 |
Customer Contacts
- Phone
- 800-213-1324
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 27 Degrees Celsius