FDA UDI
In Commercial Distribution
🇺🇸 United States
(Design) Cardinal Wings
DI: 20885380183611
·
Model: TRUAIR3036
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- (Design) Cardinal Wings
- Primary DI
- 20885380183611
- Version / Model
- TRUAIR3036
- Catalog Number
- TRUAIR3036
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-11-03
- Public Version
- 1
- Public Version Date
- 2022-11-11
- Public Version Status
- New
- Public Device Record Key
- 5aea2f3a-7bb3-46bd-81ea-092a182afb08
Device Description
Quilted TRUAIR Premium Underpad, Maximum
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 |
|---|---|---|---|---|
| 61850 | Absorbent underpad, non-antimicrobial, single-use | A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380183612 | GS1 | CASE | 4 | In Commercial Distribution | |
| Primary | 20885380183611 | GS1 | ||||
| Unit of Use | 10885380183614 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.23 | Pound |