Airlife™

Primary DI
20190752181196
Brand
Airlife™
Company
VYAIRE MEDICAL, INC.
Model
6600-0196-700
Catalog number
6600-0196-700
Device description
Infant Skin Temperature Probe, Single Patient Use
Published
2021-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMTWARMER, INFANT RADIANT

Product Code Classifications

CodeDeviceSpecialtyClass
FMTWarmer, Infant RadiantGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20190752181196PackageGS110In Commercial Distribution
50190752181197PackageGS150In Commercial Distribution
10190752181199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019075218119620190752181196
5019075218119750190752181197
1019075218119910190752181199

GMDN Terms

TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Contacts

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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