FDA.reportPublic FDA data

CPR-2 Bag

Primary DI
10641043561782
Brand
CPR-2 Bag
Company
MERCURY ENTERPRISES, INC.
Model
10-56178
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
K911622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911622000CPR BAGMerced Medical, Inc.1991-05-20BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10641043561782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064104356178210641043561782

Contacts#

Phone, Email table
PhoneEmail
(727) 573-0088hospitalcustomerservice@mercurymed.com

Regulatory Flags#

DUNS number
032705659
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10641043508473Neo-Tee T-Piece Resuscitator10-508232026-03-26
10641043563311CPR-2 Bag10-563312026-02-12
10641043564608CPR-2 Bag10-564602025-12-16
30641043564602CPR-2 Bag10-564602025-12-16
10641043320006EZflow10-320002016-03-07
10641043320013EZflow10-320012016-03-07
10641043320020EZflow10-320022016-03-09
10641043320037EZflow MAX10-320032016-03-09
10641043320044EZflow MAX10-320042016-03-09
10641043320051EZflow10-320052016-03-09
10641043320068EZflow10-320062016-03-09
10641043320099EZflow MAX10-320092016-03-09
10641043588727Hyperinflation System10-588722025-09-11
10641043566039CPR-2 Bag10-566032025-07-15
30641043566033CPR-2 Bag10-566032025-07-15
10641043913161Neo-Tee T-Piece Resuscitator CircuitM1091316VSM1091316VS2024-02-08
10641043913352Neo-Tee T-Piece Resuscitator CircuitM1091335VSM1091335VS2024-02-08
10641043913659Neo-Tee T-Piece Resuscitator CircuitM1091365VSM1091365VS2024-02-08
10641043553701StatCO2 End Tidal CO2 Detector10-553702016-01-08
30641043913165Neo-Tee T-Piece Resuscitator Circuit10-913162024-02-08

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
10889483631522AirFlow™VENTLAB, LLCBTM2025-02-03
10889483555675VentlabVENTLAB, LLCBTM2024-03-12
10889483555743VentlabVENTLAB, LLCBTM2024-03-12
10889483555750VentlabVENTLAB, LLCBTM2024-03-12
10889483555767VentlabVENTLAB, LLCBTM2024-03-12
10889483555774VentlabVENTLAB, LLCBTM2024-03-12
10889483555798VentlabVENTLAB, LLCBTM2024-03-12
10889483555804VentlabVENTLAB, LLCBTM2024-03-12
10889483555842VentlabVENTLAB, LLCBTM2024-03-12
10889483555859VentlabVENTLAB, LLCBTM2024-03-12
10889483565643AirFlowVENTLAB, LLCBTM2023-12-14
10889483111185VentlabVENTLAB, LLCBTM2023-07-12
10889483073315VentlabVENTLAB, LLCBTM2023-06-28
10889483167083VentlabVENTLAB, LLCBTM2023-06-28
10889483077573Ventlab, LLCVENTLAB, LLCBTM2023-06-26
10889483172230Ventlab, LLCVENTLAB, LLCBTM2023-06-26
00840117326002RespO2 Manual Pulmonary Resuscitator (MPR)Dynarex CorporationBTM2023-01-09
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
10193489001945MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
06946430410832CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
06946430410856CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
06946430410870CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
10193489001150MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489001167MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10190752141308AirLife™AIRLIFEBTM2021-05-03