enFlow™

Primary DI
50190752147100
Brand
enFlow™
Company
VYAIRE MEDICAL, INC.
Model
980202EU
Catalog number
980202EU
Device description
Disposable IV Fluid/Blood Warmer Cartridge with IV Extension Model 202
Published
2021-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
20190752147109PackageGS110In Commercial Distribution
50190752147100PackageGS130In Commercial Distribution
10190752147102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019075214710920190752147109
5019075214710050190752147100
1019075214710210190752147102

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
080456871
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
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10190752153158VELA11571115712021-03-29
10190752114814AirLife™0024320024322020-01-15
10190752114821AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) 0024330024332020-01-15
10190752114838AirLife™0024340024342020-01-15
10190752114845AirLife™0024350024352020-01-15
10190752114852AirLife™0024370024372020-01-15
10190752114869AirLife™0024380024382020-01-15
10190752114876AirLife™0024390024392020-01-15
10190752114883AirLife™0024400024402021-04-02
10190752114890AirLife™0024420024422020-01-15
10190752114906AirLife™0024430024432020-01-15
10190752114913AirLife™0024440024442020-01-15
10190752114920AirLife™0024450024452020-01-15
10190752114937AirLife™0024460024462020-01-15
10190752114944AirLife™0024500024502020-01-15
10190752114968AirLife™0024580024582020-01-15
10190752114975AirLife™0025010025012020-01-15
10190752114982AirLife™0025020025022020-01-15
10190752114999AirLife™0025300025302020-01-15

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