Plasma Exchange Tubeset 066I

GUDID 10868465000112

ASAHI KASEI MEDICAL AMERICA INC.

Apheresis system tubing set
Primary Device ID10868465000112
NIH Device Record Keyef67bfeb-2abe-4e5e-abdf-ae6acc5396d7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasma Exchange Tubeset
Version Model Number066I
Catalog Number066I
Company DUNS828593785
Company NameASAHI KASEI MEDICAL AMERICA INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone901-362-6105
Emailcustomerservice@akmamerica.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100868465000115 [Primary]
GS110868465000112 [Package]
Contains: 00868465000115
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-23

On-Brand Devices [Plasma Exchange Tubeset]

10868465000112066I
10868465000105064I

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