FDA UDI
In Commercial Distribution
🇺🇸 United States
EKM INFLATION DEVICE
DI: 00886333207626
·
Model: 194101
·
ARGON MEDICAL DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EKM INFLATION DEVICE
- Primary DI
- 00886333207626
- Version / Model
- 194101
- Catalog Number
- 194101
- Company Name
- ARGON MEDICAL DEVICES, INC.
- Labeler DUNS
- 140727624
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- bb308c85-0f5b-45d4-ad98-e002a6a0ae01
Device Description
EKM INFLATION DEVICE
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 |
|---|---|---|---|---|
| MAV | Syringe, Balloon Inflation | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17541 | Catheter/overtube balloon inflator, single-use | A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20886333207620 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00886333207626 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953522 | 000 |