FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Abena
DI: 05703538335136
·
Model: 9378
·
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
- Primary DI
- 05703538335136
- Version / Model
- 9378
- Company Name
- Abena North America, Inc
- Labeler DUNS
- 078740398
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-05
- Public Version
- 7
- Public Version Date
- 2026-01-01
- Public Version Status
- Update
- Public Device Record Key
- bf10cc7e-a65e-464e-9af0-ebf2e6548db7
- Distribution End Date
- 2026-01-01
Device Description
Abri-San Premium Pads 6 incontinence holds 54 fluid ounces/1200 ml which measures 12" x 25".
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 |
|---|---|---|---|---|
| 41588 | Incontinence pants, single-use | An underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated shell capable of retaining the urine of patients with light or medium incontinence while keeping the skin dry. The device is used in healthcare facilities or at home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05703538335150 | GS1 | Case | 3 | Not in Commercial Distribution | 2022-01-01 |
| Primary | 05703538335136 | GS1 |
Customer Contacts
- Phone
- 844-223-6248
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight and water.