FDA.reportPublic FDA data

VenaPulse

Primary DI
00860446000329
Brand
VenaPulse
Company
ACI MEDICAL LLC
Model
VP-25
Catalog number
VP-25
Device description
Pneumatic tourniquet to evacuate blood from limb.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903894000VENAPULSE MODELS VP-25 AND VP-50Aci Medical, Inc.1991-04-03JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860446000329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860446000329008604460003298604460003290860446000329

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic tourniquet systemA device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7607444400info@acimedical.com

Regulatory Flags#

DUNS number
153761499
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00860446000305ArtAssistAA-1000AA-10002016-09-24
00860446000312APG Air-PlethysmographAPG-1000APG-10002016-09-24

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Primary DI, Brand, Company table
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