FDA.reportPublic FDA data

Vacuum Regulator

Primary DI
00850027043319
Brand
Vacuum Regulator
Company
Precision Medical, Inc.
Model
PM3300 series w/ Vac Trap
Device description
PM3300 Series, Vac Reg, Intermittent, 200MMHG w/Vac Trap
Published
2021-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDPRegulator, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944479000PM3300 INTERMITTENT VACUUMPrecision Medical, Inc.1994-12-22KDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850027043319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850027043319008500270433198500270433190850027043319

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, general-purposeA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6102626090support@precisionmedical.com

Regulatory Flags#

DUNS number
112569116
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500270431738MFA Flowmeters8MFA6000 SERIES2021-04-19
008500270431808MFA Flowmeters8MFA7000 SERIES2021-04-19
008558870067958MFA Flowmeters8MFA O2 Series2017-04-11
008558870068018MFA Flowmeters8MFA Air Series2017-04-11
00850027043791Precision MedicalPM11102026-02-25
00850027043807Precision MedicalPM11502026-02-25
00850027043821Precision Medical Inc.5026872026-02-25
00850027043838Precision Medical Inc.502687-122026-02-25
00850027043845Precision Medical Inc.PM10002026-02-25
00850027043852Precision Medical Inc.5044502026-02-25
00850027043814Precision MedicalPM36PCCM2026-01-05
00850027043777Precision Medical5MFA Series - O25MFA2025-10-07
00850027043784Precision Medical5MFA Series - Air5MFA2025-10-07
008500270434491MFA Flowmeters1MFA2001MOD2021-04-21
008500270431281MFA Flowmeters1MFA1001MOD2021-04-19
008500270431351MFA Flowmeters1MFA9001AM2021-04-19
008500270431421MFA FlowmetersY1MFAPCFP2021-04-19
008500270431591MFA Flowmeters1MFA6000 SERIES2021-04-19
008500270431661MFA Flowmeters1MFA7000 SERIES2021-04-19
008558870067401MFA Flowmeters1MFA O2 Series2017-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344144693MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144709MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144716MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144723MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144730MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144747MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144754MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144761MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144778MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144785MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144792MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144808MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144815MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144822MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146161MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146178MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146185MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146192MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146208MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146215MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146222MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147267MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147274MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147281MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147298MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147304MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147311MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147328MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147335MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147342MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24