FDA.reportPublic FDA data

PulseFlow DF™

Primary DI
05060666850000
Brand
PulseFlow DF™
Company
COMPEDICA LIMITED
Model
PB01 Left A
Catalog number
PFDFxs-Left A
Published
2021-04-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K150806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150806000PulseFlowDFPulseflow Technologies2015-12-16JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852597007005PreviousGS10
05060666850000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852597007005008525970070058525970070050852597007005
05060666850000050606668500005060666850000

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401480273066info@dbcmed.com

Regulatory Flags#

DUNS number
226206669
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060666850048PulseFlow DF™PB01 Left CPFDFs-Left C2023-03-07
05060666850055PulseFlow DF™PB01 Right CPFDFs-Right C2023-03-07
05060666850062PulseFlow DF™PB01 Left DPFDFs-Left D2021-04-10
05060666850079PulseFlow DF™PB01 Right DPFDFs-Right D2021-04-10
05060666850109PulseFlow DF™PB01 Left FPFDFm-Left F2021-04-10
05060666850116PulseFlow DF™PB01 Right FPFDFm-Right F2021-04-10
05060666850161PulseFlow DF™PB01 Left IPFDFl-Left I2021-04-10
05060666850178PulseFlow DF™PB01 Right IPFDFl-Right I2021-04-10
05060666850208PulseFlow DF™PB01 Left KPFDFxl-Left K2021-04-10
05060666850215PulseFlow DF™PB01 Right KPFDFxl-Right K2021-04-10
05060666850024PulseFlow DF™PB01 Left BPFDFxs-Left B2021-12-29
05060666850031PulseFlow DF™PB01 Right BPFDFxs-Right B2021-12-29
05060666850017PulseFlow DF™PB01 Right APFDFxs-Right A2021-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446979128AIRCASTDJO, LLCJOW2026-08-03
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50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
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