FDA.report

Scott Medical Products

Primary DI
00819601020535
Brand
Scott Medical Products
Company
AIRGAS USA LLC
Model
Calibration gas
Catalog number
Z02NI97K350000C
Device description
Description: 3% ENFLURANE, BAL. N2; Cylinder: XL; Valve: CGA 510; For calibration of medical analyzers in accordance with manufacturer's instructions.
Published
2019-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BXKGas, Calibration (Specified Concentration)

Product Code Classifications

CodeDeviceSpecialtyClass
BXKGas, Calibration (Specified Concentration)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819601020535PrimaryGS10

GMDN Terms

TermDefinition
Multiple blood gas analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

Device Sizes

TypeValueUnit
Pressure31Pound per Square Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius52 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-233-4334customerservice.healthcare@airliquide.com

Regulatory Flags

DUNS number
831996595
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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