Vacuum Regulator

GUDID 00850027043432

PS3400 Series, Vac Reg, Intermittent, 150MMHG, DIGITAL,PRE-SET, w/Vac Trap

Precision Medical, Inc.

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Primary Device ID00850027043432
NIH Device Record Key4514d7f3-9523-4449-ba0e-2c9b82cf48d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVacuum Regulator
Version Model NumberPS3400D series w/ Vac Trap
Company DUNS112569116
Company NamePrecision Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100850027043432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDPRegulator, Vacuum

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-21
Device Publish Date2021-04-20

On-Brand Devices [Vacuum Regulator]

00850027043326PM3300 Series, Vac Reg, Intermittent, 200MMHG DIGITAL w/Vac Trap
00850027043319PM3300 Series, Vac Reg, Intermittent, 200MMHG w/Vac Trap
00850027043302PM3100 Series, Vac Reg, Cont, 300MMHG DIGITAL w/PM9000 Vac Trap
00850027043296PM3100 Series, Vac Reg, Cont, 300MMHG w/PM9000 Vac Trap
00850027043289PM3100 Series, Vac Reg, Cont, 200MMHG w/PM9000 Vac Trap
00850027043272PM3000 Series, Vac Reg, Cont, 300MMHG w/PM9000 Vac Trap
00850027043265PM3000 Series, Vac Reg, Cont, 200MMHG w/PM9000 Vac Trap
00850027043258PM3300 Series, Vac Reg, Intermittent, 300MMHG w/PM9100 Subglottic & Vac Trap
00850027043241PM3300 Series, Vac Reg, Intermittent, 300MMHG w/PM9100 Subglottic
00850027043234PM3300 Series, Vac Reg, Intermittent, 200MMHG w/PM9100 Subglottic
00850027043227PM3100 Series, Vac Reg, Cont, 3POSN, 300MMHG w/PM9100 Subglottic
00850027043210PM3100 Series, Vac Reg, Cont, 3POSN, 200MMHG w/PM9100 Subglottic
00850027043203PM3000 Series, Vac Reg, Cont, 2POSN, 300MMHG w/PM9100 Subglottic
00850027043197PM3000 Series, Vac Reg, Cont, 2POSN, 200MMHG w/PM9100 Subglottic
00850027043432PS3400 Series, Vac Reg, Intermittent, 150MMHG, DIGITAL,PRE-SET, w/Vac Trap
00850027043425PS3300 Series, Vac Reg, Intermittent, 200MMHG, DIGITAL,PRE-SET, w/Vac Trap
00850027043418PS3300 Series, Vac Reg, Intermittent, 300MMHG, PRE-SET, w/Vac Trap
00850027043401PS3300 Series, Vac Reg, Intermittent, 200MMHG, PRE-SET, w/Vac Trap
00850027043395PM3600 Series, Vac Reg, 760MMHG, DIGITAL w/Vac Trap
00850027043388PM3600 Series, Vac Reg, 760MMHG, w/Vac Trap
00850027043371PM3500 Series, Vac Reg, 150MMHG, w/Vac Trap
00850027043364PM3400 Series, Vac Reg, Intermittent, 150MMHG DIGITAL w/Vac Trap
00850027043357PM3400 Series, Vac Reg, Intermittent, 150MMHG w/Vac Trap
00850027043340PM3300 Series, Vac Reg, Intermittent, 300MMHG DIGITAL w/Vac Trap
00850027043333PM3300 Series, Vac Reg, Intermittent, 300MMHG w/Vac Trap

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