FDA UDI
In Commercial Distribution
🇺🇸 United States
Aspiration Tube Set
DI: 05391539370074
·
Model: 1.0
·
PERFUZE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aspiration Tube Set
- Primary DI
- 05391539370074
- Version / Model
- 1.0
- Catalog Number
- PA110100US
- Company Name
- PERFUZE LIMITED
- Labeler DUNS
- 985715471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-02
- Public Version
- 1
- Public Version Date
- 2023-11-10
- Public Version Status
- New
- Public Device Record Key
- 92275f5c-5956-4939-bb53-64e1105cb8b5
Device Description
The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede 070 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.
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
- 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 |
|---|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46721 | Disposable vacuum tubing | A sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391539370074 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232524 | 000 |