FDA UDI
In Commercial Distribution
🇺🇸 United States
inCourage®
DI: 00606959420557
·
Model: ICS-1M-US-A
·
Respiratory Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- inCourage®
- Primary DI
- 00606959420557
- Version / Model
- ICS-1M-US-A
- Catalog Number
- R500055-001
- Company Name
- Respiratory Technologies, Inc.
- Labeler DUNS
- 847990566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-17
- Public Version
- 1
- Public Version Date
- 2025-09-25
- Public Version Status
- New
- Public Device Record Key
- ac3257a6-9905-4076-aa4f-9d1d0a14ea69
Device Description
Pulsating Therapy Unit
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| BYI | Percussor, Powered-Electric | Anesthesiology | 868.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38123 | Chest-oscillation airway secretion-clearing system generator | A mains electricity (AC-powered) component of a high frequency chest wall oscillation airway secretion-clearing system intended to produce oscillating pressurized air-pulses that are delivered to an inflatable vest via a dedicated thick-walled hose. The air-pulses cause the vest to rapidly inflate and deflate against the chest wall of the patient promoting airway clearance by creating high frequency chest wall oscillation (HFCWO) resulting in the mobilization of bronchial secretions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00606959420557 | GS1 |
Customer Contacts
- Phone
- 1-800-793-1261
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051383 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 85 Degrees Celsius