FDA UDI
In Commercial Distribution
🇺🇸 United States
Alleset
DI: 16931918146850
·
Model: 99-UPSE1824
·
GRI Medical & Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- Alleset
- Primary DI
- 16931918146850
- Version / Model
- 99-UPSE1824
- Company Name
- GRI Medical & Electronic Technology Co., Ltd.
- Labeler DUNS
- 679894738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-06-20
- Public Version
- 1
- Public Version Date
- 2025-06-30
- Public Version Status
- New
- Public Device Record Key
- 9350143d-3f4d-4adb-aa63-930a750ba345
Device Description
Allesorb Underpad_Select__18"x24"/46x61cm_non-sterile_10ea/bag_6bag/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
- 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
- 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 |
|---|---|---|---|---|---|---|
| Package | 26931918146857 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 16931918146850 | GS1 | ||||
| Unit of Use | 06931918146853 | GS1 |
Customer Contacts
- Phone
- +86057383617385
- [email protected]