FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoart
DI: E307219101510
·
Model: MONOART® APRON PG 20 XLong
·
EURONDA SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Monoart
- Primary DI
- E307219101510
- Version / Model
- MONOART® APRON PG 20 XLong
- Catalog Number
- 21910151
- Company Name
- EURONDA SPA
- Labeler DUNS
- 428755441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-18
- Public Version
- 1
- Public Version Date
- 2020-06-26
- Public Version Status
- New
- Public Device Record Key
- 05df7a6b-3661-4685-b695-4d4c65376653
Device Description
Roll of 133 patients aprons made from a waterproof polyethylene layer. The perforated tear-off parts make the aprons easy to use. The system with laces, allows to tie apron directly to the patient’s neck. Available in two sizes (120 and 160 cm respectively), these protect patients down to the knee or ankles. Carton of 6 rolls. Dimensions: 120 x 53 cm. Colour: blue.
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 |
|---|---|---|---|---|
| KHR | Absorber, Saliva, Paper | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61048 | Patient examination/treatment drape, single-use | A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E307219101510 | HIBCC | ||||
| Package | E307219101511 | HIBCC | Aprons | 133 | In Commercial Distribution | |
| Package | E307219101512 | HIBCC | Carton | 6 | In Commercial Distribution |