FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Disposable barrier covers for Troop Elevation Pillow
DI: 10856446007038
·
Model: 10-910-03
·
CR ENTERPRISES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
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Basic Information
- Brand Name
- Disposable barrier covers for Troop Elevation Pillow
- Primary DI
- 10856446007038
- Version / Model
- 10-910-03
- Catalog Number
- 10-910-03
- Company Name
- CR ENTERPRISES, LLC
- Labeler DUNS
- 006375677
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2020-04-14
- Public Version
- 2
- Public Version Date
- 2021-09-15
- Public Version Status
- Update
- Public Device Record Key
- df6fbeeb-4cf3-4022-93d6-c39efc910f64
- Distribution End Date
- 2021-01-01
Device Description
Disposable barrier covers for Troop Elevation Pillow and Addition - 30 per box
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
- Yes
- 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 |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37456 | Pillow cover, single-use | A device made of an impermeable material that fits over a pillow, and under a pillowcase, to reduce allergen levels or for infection control. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00856446007031 | GS1 | ||||
| Primary | 10856446007038 | GS1 |
Customer Contacts
- Phone
- 972-625-5177
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30.5 | Inch | |
| Width | 20.5 | Inch |