FDA.reportPublic FDA data

Disposable Medical Hyperinflation System

Primary DI
10889483229897
Brand
Disposable Medical Hyperinflation System
Company
SUNMED, LLC
Model
7-N7910
Catalog number
7-N7910
Device description
AirLife™ Hyperinflation System, Hyperinflation Elbow, 7' O2 and Pressure Lines
Published
2025-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483229894PackageGS150In Commercial Distribution
00709078060304PreviousGS10
10889483229897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088948322989420889483229894
00709078060304007090780603047090780603040709078060304
1088948322989710889483229897

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483155912SunMed4-0050-10M4-0050-10M2023-07-18
10889483225448Septal-H™CP-5410CP-54102025-12-15
10889483225455Septal-H™CP-5500CP-55002025-12-15
10889483230244AirLife™TC-1022TC-10222025-12-15
10889483033289SunMed9-0210-019-0210-012024-03-12
10889483564578BALLARD™221036-5227036-52025-11-21
10889483040218SunMed5-0236-315-0236-312023-03-21
10889483221150AirLife™093709372025-12-18
10889483221181Vital Signs™8809-W8809-W2025-12-23
10889483221747AirLife™026202622025-12-19
10889483222027Co2 Easy5621342026-03-31
10889483222034Pedi Co2 Easy5621352026-03-31
10889483222157Ambu900-000-601900-000-6012025-12-19
10889483222164Ambu900-000-602900-000-6022025-12-19
10889483222188Ambu900-000-604900-000-6042025-12-19
10889483222195Ambu900-000-605900-000-6052025-12-19
10889483222201Ambu900-000-606900-000-6062025-12-19
10889483222225Ambu900-000-609900-000-6092025-12-19
10889483222232Ambu900-000-611900-000-6112025-12-19
10889483222393AirLife™056205622025-12-18

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