FDA UDI
In Commercial Distribution
🇺🇸 United States
Percussionaire
DI: 00849436000693
·
Model: S20020
·
PERCUSSIONAIRE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Percussionaire
- Primary DI
- 00849436000693
- Version / Model
- S20020
- Catalog Number
- S20020
- Company Name
- PERCUSSIONAIRE CORPORATION
- Labeler DUNS
- 603048778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-09
- Public Version
- 1
- Public Version Date
- 2024-01-17
- Public Version Status
- New
- Public Device Record Key
- bb597172-3945-426d-beae-6e85e5f293b9
Device Description
Distal Phasitron, Case of 5 Phasitrons
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10849436000690 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 00849436000693 | GS1 |
Customer Contacts
- Phone
- 208-263-2549
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905235 | 000 |