FDA UDI
In Commercial Distribution
🇺🇸 United States
Encompass
DI: 00609953268552
·
Model: 49416-310
·
Encompass Group, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Encompass
- Primary DI
- 00609953268552
- Version / Model
- 49416-310
- 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
- bb2391de-bcf5-4932-8695-cf271782c4f0
Device Description
PILLOWCASE T180 JADE GREEN PILLOWCASE T180 JADE GREEN 55C/45P BLEND
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 |
|---|---|---|---|---|
| FME | Gown, Examination | General Hospital | 880.6265 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47453 | Basic pillowcase, reusable | A protective envelope for a pillow typically made of a thin textile material intended to create a physical barrier to soiling and cross-contamination. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites. The device is laundered for cleaning, usually at regular intervals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50609953268557 | GS1 | CA | 60 | In Commercial Distribution | |
| Primary | 00609953268552 | GS1 |
Customer Contacts
- Phone
- 1-800-284-4540
- [email protected]