FDA UDI
In Commercial Distribution
🇺🇸 United States
FLEXFORM LINE
DI: 08033003349397
·
Model: HS GENERAL PURPOSE
·
H.S. HOSPITAL SERVICE SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FLEXFORM LINE
- Primary DI
- 08033003349397
- Version / Model
- HS GENERAL PURPOSE
- Catalog Number
- HSGPL1030
- Company Name
- H.S. HOSPITAL SERVICE SPA
- Labeler DUNS
- 428898555
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-01
- Public Version
- 1
- Public Version Date
- 2021-03-09
- Public Version Status
- New
- Public Device Record Key
- a94c92e9-a36a-407a-94a8-a888a21cdd95
Device Description
HS GENERAL PURPOSE L 10FRX30CM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47796 | Multi-purpose percutaneous abdominothoracic drainage catheter | A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28033003349391 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08033003349397 | GS1 |
Customer Contacts
- Phone
- +39069201961
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 30 | Centimeter | |
| Catheter Gauge | 10 | French |