FDA.reportPublic FDA data

MICROTEK

Primary DI
00748426074242
Brand
MICROTEK
Company
Microtek Medical LLC
Model
1
Device description
CPR FILTERSHIELD, 1-EACH
Published
2017-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980066000CPR FILTERSHIELDPlasco, Inc.1998-07-16BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50748426074247PackageGS150In Commercial Distribution
00748426074242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074842607424750748426074247
00748426074242007484260742427484260742420748426074242

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, reusable"A flexible, form-shaped device that is placed over a patient's mouth to administer ""mouth-to-mask"" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace ""mouth-to-mouth"" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device."

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store under normal warehouse conditions.

Contacts#

Phone, Email table
PhoneEmail
+1(800)824-3027customerservicemicrotekmed.com@ecolab.com

Regulatory Flags#

DUNS number
106908437
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00748426262069Medline-MicrotekProcedural Drape KitsDR40002026-10-19
00748426264575Medline-MicrotekProbe CoversPC36872026-10-14
20748426264531Medline-MicrotekProbe Covers91179N2026-10-14
20748426264593Medline-MicrotekProbe CoversPC3687N2026-10-14
20748426264623Medline-MicrotekProbe CoversPC3787N2026-10-14
00748426264605Medline-MicrotekProbe CoversPC37872026-10-13
00748426264636Medline-MicrotekProbe CoversPC45152026-10-13
00748426264568Medline-MicrotekProbe CoversPC11532026-10-12
00748426263448Convertors®Equipment Drapes29-290092026-06-09
00748426121861OLYMPUSEquipment DrapesOME-V2-D2026-05-28
00748426146802Medline-MicrotekFluid Warming - Warmer EquipmentEFW5L2026-05-20
00748426146925Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-1075EU2026-05-20
00748426146932Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-2038EU2026-05-20
00748426262076AQUABLATION THERAPY®Patient DrapesDR39002026-04-06
00748426264483Medline-MicrotekPatient Drapes5960UK2026-03-16
00748426264490Medline-MicrotekEquipment Drapes8033651EU2026-03-16
00748426264506Medline-MicrotekEquipment Drapes49652026-03-16
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483653371AirlifeVENTLAB, LLCBTM2026-10-15
10889483654286AirlifeVENTLAB, LLCBTM2026-10-15
10889483654293AirlifeVENTLAB, LLCBTM2026-10-15
10889483654309AirlifeVENTLAB, LLCBTM2026-10-15
10889483654316AirlifeVENTLAB, LLCBTM2026-10-15
00199972000474CuraplexBOUND TREE MEDICAL, LLCBTM2026-08-15
10197344097395MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097401MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097418MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097425MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097432MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097449MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100446MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100453MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100477MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100484MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344110902MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100460MEDLINEMEDLINE INDUSTRIES, INC.BTM2024-12-05
10195327558598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTM2023-12-21
10889483111185VentlabVENTLAB, LLCBTM2023-07-12
10193489139303MedlineMEDLINE INDUSTRIES, INC.BTM2023-02-04
10193489189162MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
10193489189179MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
00840117326002RespO2 Manual Pulmonary Resuscitator (MPR)Dynarex CorporationBTM2023-01-09
10193489181937MedlineMEDLINE INDUSTRIES, INC.BTM2022-11-10
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
10193489003123MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-22
10193489092400MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-12
10193489001945MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489001952MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10