FDA.reportPublic FDA data

ME+250 _ DS _ G1/2 G

Primary DI
08592346755055
Brand
ME+250 _ DS _ G1/2 G
Company
GCE, s.r.o.
Model
0735103US
Device description
MediEvac+ is variable control medical suction equipment powered from a vacuum source used for vacuum regulation. MediEvac+ is intended for suction of body liquids from any part of a patient's body during surgical operations, resuscitation, chest and gastritic drainage, etc. The product is not intended to be powered from: • a venturi vacuum source • a pressure gas source. The product is not intended for: • field use • direct use during thoracic drainage
Published
2021-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KDPRegulator, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592346755055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592346755055085923467550558592346755055

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

Regulatory Flags#

DUNS number
819753190
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592346978812MediVital EMVE25 O2 3/4UNF CGA540 DS S0718500US2025-08-08
08592346893382VarimedVM O2 CGA540 _ _ 9/16 S0729113US2025-03-17
08592346893399Varimed+VM+ O2 CGA540 _ _ 9/16 S0729114US2025-03-17
08592346893405VarimedVM O2 CGA870 _ _ 9/16 S0729115US2025-03-17
08592346893412Varimed+VM+ O2 CGA870 _ _ 9/16 S0729116US2025-03-17
08592346893429VarimedVM AIR CGA346 _ _ 9/16 S0729117US2025-03-17
08592346893436VarimedVM N2O CGA326 _ _ 9/16 S0729118US2025-03-17
08592346918276VarimedVM O2 CGA540 _ PTBH 9/16 G0729120US2025-03-17
08592346944831Varimed+VM+ N2O PI DS _ _ S0729125US2025-03-17
08592346944848VarimedVM N2O CGA326 DS _ _ S0729126US2025-03-17
08592346946033Varimed+VM+ CO2 CGA320 DS _ _ S0729127US2025-03-17
08592346946040VarimedVM CO2 CGA320 DS _ _ S0729128US2025-03-17
08592346935426Varimed+VM+ CO2 PI DS _ _ S0729123US2024-10-23
08592346935440Varimed+VM+ N2O CGA326 DS _ _ S0729124US2024-10-23
08592346935464Varimed+VM+ AIR PI DS _ _ S0729121US2024-10-23
08592346935471Varimed+VM+ AIR CGA346 DS _ _ S0729122US2024-10-23
08592346898165MediVitopMT25 O2 3/4UNF CGA540R DS S0712601US2024-06-13
08592346893443MR AIR_PI_DS _ _ G0724109US2023-12-12
08592346893450VM AIR PI _ _ 9/16 G0729119US2023-12-12
08592346892583MS25 O2 PI DS _ 9/16 S0720121US2023-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435510679101TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510679767TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510679774TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510679866TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510679873TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680039TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680046TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680053TITANIUM VAC REGHERSILL SLKDP2026-01-07
00850027043814Precision MedicalPrecision Medical, Inc.KDP2026-01-05
10197344143757MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-12-12
10197344143580MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143597MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143603MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143610MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143627MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143634MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143641MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
00850027043692Precision MedicalPrecision Medical, Inc.KDP2025-07-16
10197344146031MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-06-19
10197344146796MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-06-19
10197344134335MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-02-10
10197344134601MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-02-10
10816286021168BOEHRINGER® Offset Mount - Four InchesBOEHRINGER LABORATORIES, LLCKDP2024-12-31
10193489131390MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-10-31
10193489131406MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-10-31
10193489148282MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-10-31
10197344110087MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-07-25
10197344101740MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-07-22
10197344101757MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-07-16
10197344098996MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-07-11