FDA UDI
In Commercial Distribution
🇺🇸 United States
Care Continuum Chair
DI: 00850043655008
·
Model: CCC-1000
·
Tpm Research, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Care Continuum Chair
- Primary DI
- 00850043655008
- Version / Model
- CCC-1000
- Company Name
- Tpm Research, Inc.
- Labeler DUNS
- 098690655
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-06
- Public Version
- 1
- Public Version Date
- 2023-04-14
- Public Version Status
- New
- Public Device Record Key
- e30d358a-ee9f-44a6-80d6-ccb85bb5ad25
Device Description
The TPM Research model CCC-1000 Care Continuum Chair is a manual operator-propelled chair that is designed for transport and use of seated occupants with their associated medical equipment (including oxygen bottle or IV fluid bags). The product is equipped with an electronic positioning system that assists with occupant entry and exit.
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
- Yes
- 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 |
|---|---|---|---|---|
| INO | Chair, Positioning, Electric | Physical Medicine | 890.3110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66678 | Stand-assistive attendant-only-propelled wheelchair | An electrically-powered device designed to be used by a healthcare provider for: 1) manual (non-electric) transport of a non-bariatric patient with a disability, or without the full capacity to walk, in a seated position over a short distance (indoors or over smooth paved surfaces); and 2) electronically-assisted patient standing. It is designed as a wheelchair with small caster wheels (inadequate for occupant self-propulsion) and a seat-lifting/footrest-lowering electronic stand-assistive mechanism; it cannot be folded or readily dismantled for transport. It is typically used in hospitals and institutions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850043655008 | GS1 |
Customer Contacts
- Phone
- 205-259-8990
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 104 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 122 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal