FDA.reportPublic FDA data

AeroStat®

Primary DI
10607915116689
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915116689PackageGS15In Commercial Distribution
00607915116682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791511668910607915116689
00607915116682006079151166826079151166820607915116682

GMDN Terms#

Term, Definition table
TermDefinition
Salivary gland catheterA sterile, thin flexible tube intended to be used to access the salivary glands typically to introduce a contrast medium to enhance the radiographic images of the glands during sialography. It is typically made of metal or plastic materials [e.g., polyethylene (PE), polyurethane] and will have a short length of rigid or flexible cannula extending from its distal end. This device may also be used for intraoperative cholangiography. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge3French
Length20Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607915110123Epix Laparoscopic ScissorsCB0302016-09-24
00607915110130Epix Laparoscopic ScissorsCB0402016-09-24
00607915142087Alexis® Lighted Wound Protector-RetractorCL4022026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorCL3022026-04-22
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceC2R122026-04-22
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
00607915110147Epix Laparoscopic GrasperC41302016-08-30
00607915110154Epix Laparoscopic GrasperC41402016-08-30
00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24
00607915117382Inzii Retrieval SystemCD0012016-09-24
00607915123406Inzii Retrieval SystemCD0032016-09-24
00607915128760Epix® Reusable ProbeC72022016-08-19
00607915128777Epix® Reusable ProbeC72112016-08-19
00607915128784Epix® Reusable ProbeC72042016-08-19
00607915128791Epix® Reusable ProbeC72052016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729793328MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793335MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793342MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793359MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793366MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793373MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793380MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793397MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793403MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793410MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793427MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793434MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793441MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793458MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793465MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793472MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793489MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793496MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793502MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793519MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793526MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793533MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729029618vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030638Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030645Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030652Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729079552Flexima™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113829vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113836vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113843vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24