FDA UDI
In Commercial Distribution
🇺🇸 United States
Abena Slip XXL2
DI: 05703538486029
·
Model: 1999915798
·
Abena North America, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Abena Slip XXL2
- Primary DI
- 05703538486029
- Version / Model
- 1999915798
- Company Name
- Abena North America, Inc
- Labeler DUNS
- 078740398
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-17
- Public Version
- 2
- Public Version Date
- 2025-12-09
- Public Version Status
- Update
- Public Device Record Key
- cf46db7d-73ce-4a36-af94-5d38c10e760a
- Distribution End Date
- 2030-01-01
Device Description
Abena Slip XXL2, holds 108 fl oz/3200 ml, waist/hips 66"-100"
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | 876.5920 | 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 | 05703538486036 | GS1 | case | 4 | In Commercial Distribution | 2029-01-01 |
| Primary | 05703538486029 | GS1 |
Customer Contacts
- Phone
- 844-223-6248
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store dry, room temperature and no direct sunlight