FDA UDI
In Commercial Distribution
🇺🇸 United States
AffloVest
DI: 00816305024005
·
Model: 8100
·
Tactile Systems Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AffloVest
- Primary DI
- 00816305024005
- Version / Model
- 8100
- Company Name
- Tactile Systems Technology, Inc.
- Labeler DUNS
- 146295980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-08
- Public Version
- 2
- Public Version Date
- 2022-11-01
- Public Version Status
- Update
- Public Device Record Key
- c474a494-2687-44ed-8ef9-0ba3a9343969
Device Description
AffloVest, Small
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| BYI | Percussor, Powered-Electric | Anesthesiology | 868.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45292 | Chest-percussion airway secretion-clearing system | An assembly of devices designed to provide external mechanical percussion (rapid tapping) to the chest wall of a patient (child to adult) to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) applicator with connecting cable and a control unit. The device is portable and operated by a healthcare professional in a medical facility or in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816305024005 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122480 | 000 |