FDA.report

NA

Primary DI
00840682102827
Brand
NA
Company
GE Healthcare Finland Oy
Model
Calibration Gas, 755580
Published
2016-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BXKGAS, CALIBRATION (SPECIFIED CONCENTRATION)

Product Code Classifications

CodeDeviceSpecialtyClass
BXKGas, Calibration (Specified Concentration)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840682102827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682102827008406821028278406821028270840682102827

GMDN Terms

TermDefinition
Anaesthesia/respiratory gas flowmeter testerA device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)558-5120xx@xx.xx

Regulatory Flags

DUNS number
401966697
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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