FDA.reportPublic FDA data

Hyperinflation System

Primary DI
30641043558090
Brand
Hyperinflation System
Company
MERCURY ENTERPRISES, INC.
Model
10-55809
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHKResuscitator,Manual,Non Self-Inflating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHKResuscitator, Manual, Non Self-InflatingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001714000MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149Mercury Medical2000-11-03NHK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30641043558090PackageGS120In Commercial Distribution
10641043558096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3064104355809030641043558090
1064104355809610641043558096

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Sterilization Methods#

Method table
Method

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
true
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
10641043568385NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2020-10-16
10641043558706HyperinflationMERCURY ENTERPRISES, INC.NHK2020-06-04
10641043568491NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-12-18
10641043568507NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-12-18
10641043568460NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-12-06
10641043568484NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-12-06
10641043568477NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-11-29
10641043558683Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-09-19
10641043558690Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-09-19
10641043553916Breathing BagMERCURY ENTERPRISES, INC.NHK2018-08-30
10641043553923Breathing BagMERCURY ENTERPRISES, INC.NHK2018-08-30
10641043553930Breathing BagMERCURY ENTERPRISES, INC.NHK2018-08-30
10641043553954Breathing BagMERCURY ENTERPRISES, INC.NHK2018-08-30
10641043558119Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-01-31
10641043558126Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-01-31
10641043558232Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-01-31
10641043558669Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-06-30
10641043568415NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-06-14
10641043568392NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-04-10
10641043568408NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-04-10
10641043558638Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-04-08
10641043558645Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-04-08
10889483085356VentlabVENTLAB, LLCNHK2016-12-22
10889483085738VentlabVENTLAB, LLCNHK2016-12-22
10889483089408VentlabVENTLAB, LLCNHK2016-12-22
10889483075661VentlabVENTLAB, LLCNHK2016-12-21
10889483080986VentlabVENTLAB, LLCNHK2016-12-21
10889483082256VentlabVENTLAB, LLCNHK2016-12-21
10889483083475VentlabVENTLAB, LLCNHK2016-12-21
10889483084571VentlabVENTLAB, LLCNHK2016-12-21