FDA UDI
In Commercial Distribution
🇺🇸 United States
Astra
DI: 05060488573668
·
Model: TC19A-BLK
·
PROACTIVE MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Astra
- Primary DI
- 05060488573668
- Version / Model
- TC19A-BLK
- Catalog Number
- TC19A-BLK
- Company Name
- PROACTIVE MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 078582655
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-17
- Public Version
- 3
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 000f03d6-0852-4356-8f38-1f17857c5b58
Device Description
Astra Transport Chair 19 inch Aluminum 250lb Wt-Cap. w/ Nylon Seat, Black
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| IOR | Wheelchair, mechanical | Physical Medicine | 890.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41630 | Attendant-only-propelled wheelchair, non-bariatric | A non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060488573668 | GS1 |
Customer Contacts
- Phone
- +1 (855) 237 7622
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 33 | Inch | |
| Width | 13 | Inch | |
| Height | 37 | Inch |