FDA.reportPublic FDA data

VasoPress

Primary DI
20815245010271
Brand
VasoPress
Company
COMPRESSION THERAPY CONCEPTS, INC.
Model
VP510L
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K101915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101915000VASOPRESS SUPREME MINI MODEL VP500DMCompression Therapy Concepts, Inc.2010-08-06JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815245010267PackageGS15In Commercial Distribution
20815245010271PackageGS150In Commercial Distribution
00815245010253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081524501026710815245010267
2081524501027120815245010271
00815245010253008152450102538152450102530815245010253

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression system pumpAn electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the cyclical inflation and deflation of a single-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Feet

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7325440800info@ctcdvt.com

Regulatory Flags#

DUNS number
788065217
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815245010000VasopressVP5002016-09-22
00815245010031VasopressVP500D2016-09-22
00815245010062VasopressVP500DM2016-09-22
00815245010222VasoPressVP5102016-09-22
00815245010253VasoPressVP510L2016-09-22
00815245010284VasoPressVP501P2016-09-22
00815245010338VasoPressVP501M2017-03-09
00815245010383VasoPressVP501L2016-09-22
00815245010437VasoPressVP501B2016-09-22
00815245010536VasoPressVP5202016-09-22
00815245010581VasoPressVP520L2016-09-22
00815245010635VasoPressVP530M2016-09-22
00815245010680VasoPressVP530L2016-09-22
00815245010734VasoPressVP530B2016-09-22
00815245010789VasoPressVP501MG2016-09-22
00815245010833VasoPressVP501LG2016-09-22
00815245010888VasoPressVP530MG2016-09-22
00815245010932VasoPressVP530LG2016-09-22
00815245010987VasoGradVG501M2016-09-22
00815245011038VasoGradVG501L2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
04719893351026WellellWellell Inc.JOW2026-03-17
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25