FDA UDI
In Commercial Distribution
🇺🇸 United States
CELLO™, Balloon Guide Catheter
DI: 04544050120722
·
Model: 1610570
·
FUJI SYSTEMS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- CELLO™, Balloon Guide Catheter
- Primary DI
- 04544050120722
- Version / Model
- 1610570
- Company Name
- FUJI SYSTEMS CORPORATION
- Labeler DUNS
- 715919973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-18
- Public Version
- 2
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 6304d0ca-32b4-4e56-b33c-cfc8d637c93b
Device Description
The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32584 | Intravascular occluding balloon catheter, image-guided | A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04544050120722 | GS1 | ||||
| Package | 14544050120729 | GS1 | 1 | In Commercial Distribution | ||
| Previous | 04544050093460 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120781 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 7F | ||
| Outer Diameter | 2.4 | Millimeter | |
| Catheter Inner Diameter | 1.70 | Millimeter | |
| Shaft Length | 950 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 54 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry, dark place