PulseFlow DF™

GUDID 00852597007357

PULSE FLOW TECHNOLOGIES

Intermittent venous compression system

Primary Device ID	00852597007357
NIH Device Record Key	529f219f-d5bc-4fac-a17e-d222d7376932
Commercial Distribution Status	In Commercial Distribution
Brand Name	PulseFlow DF™
Version Model Number	PB01 Right W I
Company DUNS	064172897
Company Name	PULSE FLOW TECHNOLOGIES
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx
Phone	+441296678596
Email	xxx@xxx.xxx

Operating and Storage Conditions

Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852597007357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K150806

FDA Product Code

JOW	Sleeve, Limb, Compressible

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-02-10

On-Brand Devices [PulseFlow DF™]

00852597007395	PB01 Right K
00852597007388	PB01 Left K
00852597007371	PB01 Right J
00852597007364	PB01 Left J
00852597007357	PB01 Right W I
00852597007340	PB01 Left W I
00852597007333	PB01 Right W H
00852597007326	PB01 Left W H
00852597007319	PB01 Right W G
00852597007302	PB01 Left W G
00852597007296	PB01 Right W F
00852597007289	PB01 Left W F
00852597007272	PB01 Right W E
00852597007265	PB01 Left W E
00852597007258	PB01 Right W D
00852597007241	PB01 Left W D
00852597007234	PB01 Right W C
00852597007227	PB01 Left W C
00852597007210	PB01 Right W B
00852597007203	PB01 Left W B
00852597007197	PB01 Right W A
00852597007180	PB01 Left W A
00852597007173	PB01 Right I
00852597007166	PB01 Left I
00852597007159	PB01 Right H
00852597007142	PB01 Left H
00852597007135	PB01 Right G
00852597007128	PB01 Left G
00852597007111	PB01 Right F
00852597007104	PB01 Left F
00852597007098	PB01 Right E
00852597007081	PB01 Left E
00852597007074	PB01 Right D
00852597007067	PB01 Left D
00852597007050	PB01 Right C
00852597007043	PB01 Left C
00852597007036	PB01 Right B
00852597007029	PB01 Left B
00852597007012	PB01 Right A
00852597007005	PB01 Left A