FDA.reportPublic FDA data

enFlow™

Primary DI
10190752125803
Brand
enFlow™
Company
AIRLIFE
Model
980121EU
Catalog number
980121EU
Device description
Controller Model 121
Published
2021-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGZWarmer, thermal, infusion fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130867000ENFLOW IV FLUID WARMER INSULATED STRAPVital Signs, Inc., A GE Healthcare Company2013-06-14LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190752125803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075212580310190752125803

GMDN Terms#

Term, Definition table
TermDefinition
Convection blood/fluid warmer setA sterile device(s) used in conjunction with a convection blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It may consist of coiled tubing, or other design, through which blood/fluid flows from the infusion bag to the patient while being heated in-line by the warmer; clamps and a bubble trap may be included. The set is typically used in the operating room (OR) or in accident and emergency (A&E) situations when rapid infusion of several units of blood/fluid is necessary. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 ml0026200026202025-02-20
10889483617007AirLife™RC6Y023034RC6Y0230342025-02-27
10889483618264Air LifeAM-20002026-08-26
10889483618271Air LifeAM-21002026-08-26
10889483618288Air LifeAM-22002026-08-26
10889483618295Air LifeAM-30002026-08-26
10889483618301Air LifeAM-31002026-08-26
10889483618318Air LifeAM-32002026-08-26
10190752118379Vital Signs™2L39882L39882019-12-20
10190752118430Vital Signs™5030AE5030AE2020-02-20
10190752118973Vital Signs™5236AAE5236AAE2019-12-20
10190752119017Vital Signs™5372AE5372AE2019-12-20
10190752119215Vital Signs™A1UXOXXXA1UXOXXX2019-12-20
10190752119246Vital Signs™A1ZX1XXXA1ZX1XXX2020-02-20
10190752119369Vital Signs™A46517XXA46517XX2019-12-20
10190752119437Vital Signs™A46X8XXXA46X8XXX2019-12-20
10190752119628Vital Signs™A4FX1XXXA4FX1XXX2019-12-20
10190752119680Vital Signs™A4FX20X4VA4FX20X4V2020-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B286DWC182464TG4B220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243064T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGLHMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC1518224B1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC151822LHNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286SWC242424GNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464T4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464TMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR2SB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286243074TGMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-17
B286SWC242464GMB1single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-14
00841027105749Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-24
00841027105725Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-12
00841027104766Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-06-02
00841027104728Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104735Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104742Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12