FDA UDI
In Commercial Distribution
🇺🇸 United States
Devon
DI: 10884521208285
·
Model: 580060
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Devon
- Primary DI
- 10884521208285
- Version / Model
- 580060
- Catalog Number
- 580060
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2018-06-29
- Public Version
- 2
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- db20af5b-e8b3-498a-8ab5-7b38850ec9f4
Device Description
Foam Arm Protector with Velcro Straps
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| CCX | SUPPORT, PATIENT POSITION | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42328 | Foam-filled bed mattress overlay | A foam-filled pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521208282 | GS1 | CASE | 12 | In Commercial Distribution | |
| Primary | 10884521208285 | GS1 | ||||
| Unit of Use | 40884521208286 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 27 | Inch | |
| Device Size Text, specify | Length, 1.75, IN; | ||
| Height | 20 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- none;