D-Stat® Clamp topical hemostat accessory

Primary DI
M20630301
Brand
D-Stat® Clamp topical hemostat accessory
Company
Vascular Solutions, Inc.
Model
3030
Published
2016-09-15
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
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20630301PackageHIBCC5In Commercial Distribution
M20630300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery compression padA sterile medicated device designed to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization. It can be used as an alternative to direct hand pressure. It consists of a lyophilized pad containing various substances/pharmaceuticals (e.g., thrombin, sodium carboxymethylcellulose, and calcium chloride) with a plastic base and may be used alone or in conjunction with other devices, e.g., held in place with a bandage, belt or straps secured around the patient's hips/thigh. It is typically used following arterial/venous puncture, coronary angiography/ventriculography, and valvuloplasty. 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
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
false
Sterilization required before use
false

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Primary DI, Brand, Company table
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