AeroStat®
- Primary DI
- 00607915116682
- Brand
- AeroStat®
- Company
- APPLIED MEDICAL RESOURCES CORPORATION
- Model
- C1002
- Device description
- Indicated for use during open and laparoscopic cholecystectomy procedures to inject radiopaque media through the cystic duct into the biliary tree.
- Published
- 2015-08-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
appliedmedical.comProduct Codes#
| Code | Name |
|---|---|
| FGE | Catheter, Biliary, Diagnostic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10607915116689 | Package | GS1 | 5 | In Commercial Distribution |
| 00607915116682 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10607915116689 | 10607915116689 | ||
| 00607915116682 | 00607915116682 | 607915116682 | 0607915116682 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cholangiography catheter | A flexible, single-lumen tube intended to be introduced into the biliary system (Hartmann’s pouch and/or cystic duct), via a surgically-created incision, to allow injection of contrast media during open, laparoscopic and/or percutaneous cholangiography; it does not include a needle. It may include disposable devices dedicated to catheter introduction/function (e.g., adaptor, guide sleeve). This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 3 | French |
| Length | 20 | Centimeter |
Contacts#
| Phone | |
|---|---|
| 1.949.713.8300 | contact@appliedmedical.com |
Regulatory Flags#
- DUNS number
- 187129135
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
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