FDA UDI
In Commercial Distribution
🇺🇸 United States
Safe N Simple
DI: 00810040135170
·
Model: SNS7501134-NF
·
SAFE N' SIMPLE LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Safe N Simple
- Primary DI
- 00810040135170
- Version / Model
- SNS7501134-NF
- Catalog Number
- SNS7501134-NF
- Company Name
- SAFE N' SIMPLE LLC
- Labeler DUNS
- 807812412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-11-08
- Public Version
- 2
- Public Version Date
- 2025-05-13
- Public Version Status
- Update
- Public Device Record Key
- 64bffd44-e8e6-4afd-924e-0d31e7d5e58e
Device Description
9" Urostomy 2-Piece Pouch Beige 50 mm 2" Flange with Valve and Belt Tabs
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXG | Bag, Urine Collecting, Ureterostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31069 | Multiple-piece urostomy bag, open-ended | A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. 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 | 00810040135163 | GS1 | ||||
| Primary | 00810040135170 | GS1 |
Customer Contacts
- Phone
- 248 214 4877
- [email protected]