FDA.reportPublic FDA data

Auto-Fill® syringe kit

Primary DI
M20676000
Brand
Auto-Fill® syringe kit
Company
Vascular Solutions, Inc.
Model
7600
Device description
The AUTO-FILL Syringe Kit is indicated for introduction of dilute lidocaine solutions into the subcutaneous tissue for the purposes of local anesthesia.
Published
2016-09-06
Public version status
Update
Distribution status
Not 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
FMFSyringe, Piston
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20676001PackageHIBCC10In Commercial Distribution
M20676000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Syringe autofill kitA collection of sterile devices designed to deliver (autofill) fluids (e.g., a dilute lidocaine solution for local anaesthesia) from an intravenous (IV) bag to a syringe so that the syringe is conveniently refilled, thus eliminating the need for multiple reconnections to the solution container. It is typically made of plastic materials and consists of a 12 cc control syringe, IV tubing with a spike, check valve and tubing clamp, and an extension line. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-240-6001customerservice@vasc.com

Regulatory Flags#

DUNS number
008999906
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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M206780300SmartNeedle® vascular access system780302016-09-05
M206780400SmartNeedle® vascular access system780402016-09-06
M206720000SmartNeedle® monitor720002016-09-23
M20631010Thrombix® Hemostasis Patch topical hemostat31012016-09-15
M20630100D-Stat® 2 Dry topical hemostat30102016-09-15
M20681500Teirstein Edge™ device organizer81502016-09-05
M20681510Angio Assist™ docking station81512016-09-05
M20673710Axis™ guidewire73712016-09-05
M20673720Axis™ guidewire73722016-09-05
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M20674730VSI Tru-Torque™ guidewire74732016-09-05
M20674790Amplatz SST™ guidewire74792016-09-05

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