FDA.reportPublic FDA data

Disposable Medical Hyperinflation System

Primary DI
20889483229894
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
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation
NHKResuscitator, Manual, Non Self-Inflating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
069009268
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
false
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
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
10889483231494Ambu900-000-614900-000-6142025-12-19
10889483231524Ambu900-000-617900-000-6172025-12-19
10889483231531Ambu900-000-618900-000-6182025-12-19
10889483231586Ambu900-000-624900-000-6242025-12-19
10889483231616Ambu900-000-628900-000-6282025-12-19
10889483565339BALLARD™97012970122025-12-01
10889483565346BALLARD™97014970142025-12-01
10889483565360BALLARD™97020970202025-12-01
10889483565377BALLARD™97021970212025-12-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483222157AmbuSUNMED, LLCBZR2025-12-19
10889483222164AmbuSUNMED, LLCBZR2025-12-19
10889483222188AmbuSUNMED, LLCBZR2025-12-19
10889483222195AmbuSUNMED, LLCBZR2025-12-19
10889483222201AmbuSUNMED, LLCBZR2025-12-19
10889483222225AmbuSUNMED, LLCBZR2025-12-19
10889483222232AmbuSUNMED, LLCBZR2025-12-19
10889483231494AmbuSUNMED, LLCBZR2025-12-19
10889483231524AmbuSUNMED, LLCBZR2025-12-19
10889483231531AmbuSUNMED, LLCBZR2025-12-19
10889483231586AmbuSUNMED, LLCBZR2025-12-19
10889483231616AmbuSUNMED, LLCBZR2025-12-19
09420012480347F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBZR2025-10-29
07630002800754HAMILTON-T1Hamilton Medical AGBZR2024-08-21
07630002813426HAMILTON-C1Hamilton Medical AGBZR2022-01-26
07630002813532HAMILTON-T1Hamilton Medical AGBZR2022-01-26
07630002813549HAMILTON-T1Hamilton Medical AGBZR2022-01-26
10190752149717AirLife™AIRLIFEBZR2021-05-03
10190752156401AirLife™AIRLIFEBZR2021-05-03
10190752156449AirLife™AIRLIFEBZR2021-05-03
10190752156463AirLife™VYAIRE MEDICAL, INC.BZR2021-05-03
10190752156470AirLife™AIRLIFEBZR2021-05-03
10190752156494AirLife™AIRLIFEBZR2021-05-03
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