Wells Johnson Elite Infiltrator/Aspirator 20-5061-00

GUDID B458205061000

Wells Johnson Elite Infiltrator/Aspirator, 110-120VAC 50Hz, 115-120VAC 60Hz

The Wells Johnson Company

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Primary Device IDB458205061000
NIH Device Record Key93360f71-cb33-4077-b7d0-ca0a9cbb9ba7
Commercial Distribution StatusIn Commercial Distribution
Brand NameWells Johnson Elite Infiltrator/Aspirator
Version Model Number20506100
Catalog Number20-5061-00
Company DUNS048931625
Company NameThe Wells Johnson Company
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB458205061000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTAPump, Portable, Aspiration (Manual Or Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-28
Device Publish Date2023-11-20

On-Brand Devices [Wells Johnson Elite Infiltrator/Aspirator]

B458205066000Wells Johnson Elite Infiltrator/Aspirator, 220-240VAC 50Hz, 230-240VAC 60Hz
B458205061000Wells Johnson Elite Infiltrator/Aspirator, 110-120VAC 50Hz, 115-120VAC 60Hz
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