FDA.reportPublic FDA data

Indeflator

Primary DI
08717648015274
Brand
Indeflator
Company
ABBOTT VASCULAR INC.
Model
1000186-115
Catalog number
1000186-115
Device description
"20/30 PRIORITY PACK Accessory Kit includes INDEFLATOR Inflation Device 30 atm 20 cc / Rotating Hemostatic Valve .115 "" / Guide Wire Introducer / Torque Device"
Published
2016-08-05
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#

Product Codes#

Code, Name table
CodeName
MAVSyringe, balloon inflation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAVSyringe, Balloon InflationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648015274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648015274087176480152748717648015274

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, dark, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags#

DUNS number
964569052
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717648175060StarClose SE™ 14679-0514679-052014-11-21
08717648000621Prostar™ 12322-0112322-012014-11-21
08717648199059XIENCE ALPINE1125225-081125225-082014-11-21
08717648199066XIENCE ALPINE1125225-121125225-122014-11-21
08717648199073XIENCE ALPINE1125225-151125225-152014-11-21
08717648199080XIENCE ALPINE1125225-181125225-182014-11-21
08717648199097XIENCE ALPINE1125225-231125225-232014-11-21
08717648199103XIENCE ALPINE1125225-281125225-282014-11-21
08717648199141XIENCE ALPINE1125250-081125250-082014-11-21
08717648199158XIENCE ALPINE1125250-121125250-122014-11-21
08717648199165XIENCE ALPINE1125250-151125250-152014-11-21
08717648199172XIENCE ALPINE1125250-181125250-182014-11-21
08717648199189XIENCE ALPINE1125250-231125250-232014-11-21
08717648199196XIENCE ALPINE1125250-281125250-282014-11-21
08717648199202XIENCE ALPINE1125250-331125250-332014-11-21
08717648199219XIENCE ALPINE1125250-381125250-382014-11-21
08717648199233XIENCE ALPINE1125275-081125275-082014-11-21
08717648199240XIENCE ALPINE1125275-121125275-122014-11-21
08717648199257XIENCE ALPINE1125275-151125275-152014-11-21
08717648199264XIENCE ALPINE1125275-181125275-182014-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2026-05-20
00884450021347DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
10884450021344DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
00884450021262DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
10884450021269DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
00884450021255DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
10884450021252DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
00856877002742QL Locking Syringe DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00884450830697Monarch®Merit Medical Systems, Inc.MAV2024-12-20
06943718223344DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223351DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223368DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223375DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223382DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223337DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223341DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223358DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223365DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223372DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223389DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
00884450851722Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851753Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851760Monarch®Merit Medical Systems, Inc.MAV2024-10-03
20197344104939NAMICMEDLINE INDUSTRIES, INC.MAV2024-09-09
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
20197344013781NAMICMEDLINE INDUSTRIES, INC.MAV2024-06-14