DiSorb Systems, Inc.
- Primary DI
- B704DISV1025
- Brand
- DiSorb Systems, Inc.
- Company
- STRADIS MEDICAL LLC
- Model
- DISV102
- Device description
- IV STAR KIT
- Published
- 2020-10-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| FPA | Set, Administration, Intravascular |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FPA | Set, Administration, Intravascular | General Hospital | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B704DISV1025 | Package | HIBCC | 50 | In Commercial Distribution |
| B704DISV1020 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Peripheral intravenous catheterization support kit | A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device. |
Regulatory Flags
- DUNS number
- 043537671
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| M752HCT8249CP3A5 | Stradis Medical, LLC. | HCT8249CP-3A | | 2020-11-03 |
| M752HCT900CHX0 | ARTERIAL LINE DRESSING CHANGE KIT | HCT900CHX | | 2022-01-10 |
| M752TMCLK15 | Stradis Medical, LLC | TMCLK-1 | | 2019-12-23 |
| M7525113885 | Stradis Medical, LLC. | 511388 | | 2020-03-25 |
| M752BRF060MSP201DC5 | Stradis Medical, LLC. | BRF-060MSP201DC | | 2019-08-01 |
| M752CD22005 | Stradis Medical, LLC | CD-2200 | | 2019-08-29 |
| M752DC5485 | Stradis Medical, LLC. | DC-548 | | 2019-12-20 |
| M752DC8903CP25 | Stradis Medical, LLC | DC8903CP-2 | | 2021-09-01 |
| M752IM12675 | Stradis Medical, LLC. | IM1267 | | 2020-06-12 |
| M752MSDCC183000 | DRESSING CHANGE TRAY | MSDC-C18300 | | 2022-05-16 |
| M752HCT5975OKB0 | Stradis Medical, LLC. | HCT5975OK-B | | 2021-04-09 |
| M752HCT7478PIV2A5 | Stradis Medical, LLC. | HCT7478PIV2A | | 2021-04-21 |
| M752HCT8428CP25 | Stradis Medical, LLC. | HCT8428CP-2 | | 2020-11-23 |
| M752HCT984915 | Stradis Medical, LLC. | HCT9849-1 | | 2020-06-08 |
| M75257029021 | PATIENT PACK NSU V2 | 570-2902 | | 2022-05-03 |
| M57257028311 | IV START KIT | 570-2831 | | 2022-03-28 |
| M752HCT200GDBP5 | Stradis Medical, LLC | HCT200GD-BP | | 2021-10-06 |
| M752RWM69KTA015 | Stradis Medical, LLC | RWM-69K-TA01 | | 2021-09-30 |
| M752WC2505 | Stradis Medical, LLC. | WC-250 | | 2021-08-23 |
| M752HCT354822 | Stradis Medical, LLC | HCT3548-2 | | 2021-08-13 |
Other Devices Sharing Product Codes