FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 50885380046986
·
Model: CA801TLB
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 50885380046986
- Version / Model
- CA801TLB
- Catalog Number
- CA801TLB
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2021-10-26
- Public Version
- 1
- Public Version Date
- 2021-11-03
- Public Version Status
- New
- Public Device Record Key
- 4c1af5e0-93db-4457-89b3-13544d7094cd
Device Description
CRUTCHES ADULT BARIATRIC TALL PUSH BUTTON ADJUSTABLE 70IN-78IN STEEL 650LB
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IPR | CRUTCH | Physical Medicine | 890.3150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31115 | Axillary crutch | A staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10885380046988 | GS1 | ||||
| Primary | 50885380046986 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 35 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius