FDA UDI
In Commercial Distribution
🇺🇸 United States
Passeo-35 Xeo
DI: 07640130452589
·
Model: 3/100/130
·
Biotronik AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Passeo-35 Xeo
- Primary DI
- 07640130452589
- Version / Model
- 3/100/130
- Catalog Number
- 428887
- Company Name
- Biotronik AG
- Labeler DUNS
- 480862817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-28
- Public Version
- 1
- Public Version Date
- 2023-03-08
- Public Version Status
- New
- Public Device Record Key
- 23ed8f50-0cff-452c-8792-6842832a5a09
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 |
|---|---|---|---|---|
| LIT | Catheter, angioplasty, peripheral, transluminal | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17184 | Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640130452589 | GS1 |
Customer Contacts
- Phone
- +1(888)345-0374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222065 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length: 100 mm | ||
| Device Size Text, specify | Diameter: 3 mm | ||
| Device Size Text, specify | Usable Length: 130 cm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Store in a dry location. Short-term temperature excursions between 50 Degr. F and 104 Degr. F allowed