FDA UDI
In Commercial Distribution
🇺🇸 United States
ICP
DI: 00688162000481
·
Model: 1
·
ICP MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ICP
- Primary DI
- 00688162000481
- Version / Model
- 1
- Catalog Number
- ICP-9003GUR
- Company Name
- ICP MEDICAL, LLC
- Labeler DUNS
- 078780963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-13
- Public Version
- 2
- Public Version Date
- 2025-08-13
- Public Version Status
- Update
- Public Device Record Key
- 7ab85458-509c-4c11-b01e-744f8984915a
Device Description
Stretcher Sheet, White, SMS 108x51
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMW | Cover, Mattress (Medical Purposes) | General Hospital | 880.6190 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37455 | Waterproof bed mattress cover, reusable | 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. It can be laundered for cleaning. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00688162000481 | GS1 | ||||
| Package | 10688162000488 | GS1 | Bag | 10 | In Commercial Distribution | |
| Package | 20688162000485 | GS1 | Bag | 10 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 96 | Inch | |
| Width | 37 | Inch |