FDA UDI
In Commercial Distribution
🇺🇸 United States
Encompass
DI: 00609953369488
·
Model: 50035-272
·
Encompass Group, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Encompass
- Primary DI
- 00609953369488
- Version / Model
- 50035-272
- Company Name
- Encompass Group, L.L.C.
- Labeler DUNS
- 121788819
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-17
- Public Version
- 2
- Public Version Date
- 2023-05-05
- Public Version Status
- Update
- Public Device Record Key
- a71ccb2b-06f3-47ee-a85a-973a1c217ab3
Device Description
SHEET DRAW PERCALE 54X72 CEIL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47455 | Basic bed sheet, reusable | A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material and is laundered for cleaning between periods of use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50609953369483 | GS1 | CA | 36 | In Commercial Distribution | |
| Primary | 00609953369488 | GS1 |
Customer Contacts
- Phone
- 1-800-284-4540
- [email protected]