FDA UDI
In Commercial Distribution
🇺🇸 United States
SimPro™ Set
DI: 07333387043739
·
Model: 5301400
·
Wellspect AB
Product Codes
5
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- SimPro™ Set
- Primary DI
- 07333387043739
- Version / Model
- 5301400
- Catalog Number
- 5301400
- Company Name
- Wellspect AB
- Labeler DUNS
- 351118942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-02
- Public Version
- 2
- Public Version Date
- 2024-12-12
- Public Version Status
- Update
- Public Device Record Key
- b83d2adc-766b-4702-bb37-27e3134e2eae
Device Description
Single Use Urinary Catheter with water sachet and Accessories. Male Nelaton 16" 14FR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZD | Catheter, straight | Gastroenterology, Urology | 876.5130 | 2 |
| LYZ | Vinyl patient examination glove | General Hospital | 880.6250 | 1 |
| FAQ | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE | Gastroenterology, Urology | 876.5250 | 1 |
| NWO | Kit, catheter, urinary (exludes HIV testing) | Gastroenterology, Urology | 876.5130 | 2 |
| EYY | Drape, urological, disposable | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45605 | Single-administration urethral catheterization kit, single-use | A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333387043753 | GS1 | 4 | In Commercial Distribution | ||
| Package | 07333387043746 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 07333387043739 | GS1 | ||||
| Previous | 07392532189333 | GS1 |
Customer Contacts
- Phone
- +1(877)456-3742
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Inch | |
| Catheter Gauge | 14 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place at room temperature.