WAVES Transport Bag 3930140.007

GUDID BI54W39301400070

Transport bag specifically designed to accommodate a running WAVES unit to allow easier handling for transplant activities.

WATERS MEDICAL SYSTEMS, LLC

Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set
Primary Device IDBI54W39301400070
NIH Device Record Keya947301b-07f6-4a00-aaba-1892d1766d3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameWAVES Transport Bag
Version Model NumberWAVES Transport Bag
Catalog Number3930140.007
Company DUNS556957871
Company NameWATERS MEDICAL SYSTEMS, LLC
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCBI54W39301400070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2017-02-12

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