FDA UDI
In Commercial Distribution
🇺🇸 United States
Alleset
DI: 16931918181783
·
Model: Model UIMP4490-1
·
GRI Medical & Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Alleset
- Primary DI
- 16931918181783
- Version / Model
- Model UIMP4490-1
- Company Name
- GRI Medical & Electronic Technology Co., Ltd.
- Labeler DUNS
- 679894738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-02-27
- Public Version
- 2
- Public Version Date
- 2022-02-21
- Public Version Status
- Update
- Public Device Record Key
- e3f1a31b-5f8f-4804-984f-83c2c9660ccd
Device Description
Allesorb Underpad_Impervious_44"x90"/112x229cm_non-sterile_Bulk Packed_100ea/cs
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
- No
- 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 |
|---|---|---|---|---|
| FRL | FIBER, MEDICAL, ABSORBENT | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61850 | Absorbent underpad, non-antimicrobial, single-use | A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. 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 | 06931918181786 | GS1 | ||||
| Primary | 16931918181783 | GS1 |
Customer Contacts
- Phone
- +86057383617385
- [email protected]