FDA UDI
In Commercial Distribution
🇺🇸 United States
Wings
DI: 10884527001415
·
Model: 7158
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
75
Basic Information
- Brand Name
- Wings
- Primary DI
- 10884527001415
- Version / Model
- 7158
- Catalog Number
- 7158
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2018-06-27
- Public Version
- 2
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- bf6acb3c-eb2c-4a1c-bd98-9efc39c47a35
Device Description
Underpad with Polymer Impregnated Tissue,Heavy
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 |
|---|---|---|---|---|
| KME | BEDDING, DISPOSABLE, MEDICAL | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35181 | Waterproof bed mattress cover, single-use | A device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. This is a single-patient device intended to be used for a limited time, without laundering, until considered inappropriate for further use and then discarded (e.g., incinerated). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884527001415 | GS1 | ||||
| Unit of Use | 20884527001412 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 30 | Inch | |
| Length | 30 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- This side up;