FDA UDI
In Commercial Distribution
🇺🇸 United States
Sphere™ Inflation Device
DI: 00827002349032
·
Model: QL6015
·
ATRION MEDICAL PRODUCTS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sphere™ Inflation Device
- Primary DI
- 00827002349032
- Version / Model
- QL6015
- Catalog Number
- CID-60-15
- Company Name
- ATRION MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 047571476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 6
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- 1db71063-138e-4b8e-9a99-3565c033095c
Device Description
Inflation Device Atrion Part Number 96378A: 60mL, 15atm
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 |
|---|---|---|---|---|
| KOE | Dilator, Urethral | Gastroenterology, Urology | 876.5520 | 2 |
| 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 | 10827002349039 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00827002349032 | GS1 |
Customer Contacts
- Phone
- +1(800)343-9334
- [email protected]