FDA UDI
In Commercial Distribution
🇺🇸 United States
Clever Choice Comfort Protect
DI: 00850002860375
·
Model: SDI-AUP
·
S.D.I. USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
150
Basic Information
- Brand Name
- Clever Choice Comfort Protect
- Primary DI
- 00850002860375
- Version / Model
- SDI-AUP
- Catalog Number
- 50002-0860-37
- Company Name
- S.D.I. USA, INC.
- Labeler DUNS
- 116722847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2019-11-13
- Public Version
- 4
- Public Version Date
- 2022-02-21
- Public Version Status
- Update
- Public Device Record Key
- fcb35da8-b6d3-4683-b150-b6d6d721019c
Device Description
Clever Choice Comfort Protect Adult Underpads - 30" x 36" 150 pack
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00850002860375 | GS1 | ||||
| Unit of Use | 20850002860379 | GS1 |
Customer Contacts
- Phone
- 1.877.342.2385
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 30 | Inch | |
| Length | 36 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool, Dry Place