FDA UDI
In Commercial Distribution
🇺🇸 United States
EZDilate
DI: 00821925033276
·
Model: BD-410X-2055
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EZDilate
- Primary DI
- 00821925033276
- Version / Model
- BD-410X-2055
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-04
- Public Version
- 4
- Public Version Date
- 2023-11-22
- Public Version Status
- Update
- Public Device Record Key
- d7b43b31-53b8-4dea-a039-fec0ff8118b5
Device Description
EZDilate - Wire Guided Esophageal / Colonic / Biliary 3-Stage Balloon Dilatiation 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 |
|---|---|---|---|---|
| KNQ | Dilator, esophageal | Gastroenterology, Urology | 876.5365 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62965 | Oesophageal warming balloon catheter | A sterile, flexible device with a distal balloon intended to be introduced into the oesophagus adjacent to the left atrium as a conduit for thermally regulated fluid, to maintain the temperature of oesophageal tissue during cardiac cryosurgical ablation to prevent oesophageal fistulas (injury). It is typically connected via tubing to fluid bags (e.g., saline bags) which may be included. The solution is intended to be warmed and then pumped through the distal balloon using an external thermal regulation/pumping assembly (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925033276 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143609 | 000 |