FDA.report

Scott Medical Practive

Primary DI
00819601021280
Brand
Scott Medical Practive
Company
AIRGAS USA LLC
Model
Calibration Gas
Catalog number
Z04NI38MSD0000
Device description
Description: 1.5% Isoflurane, 10% CO2, 50% N2O, Bal. N2; Cylinder: SD; Valve: CGA 600; For calibration of medical analyzers in accordance with manufacturer's instructions.; CE Marked
Published
2019-12-22
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

Contact Domains

Product Codes

CodeName
BXKGas, Calibration (Specified Concentration)

Product Code Classifications

CodeDeviceSpecialtyClass
BXKGas, Calibration (Specified Concentration)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819601021280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819601021280008196010212808196010212800819601021280

GMDN Terms

TermDefinition
Ether anaesthesia vaporizerA device used to vaporize the anaesthetic agent ether and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator, but some types may be used as stand-alone devices.

Device Sizes

TypeValueUnit
Pressure90Pound 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

Other Devices From This Company

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00819601021938Scott Medical ProductsCalibration GasZ03OX508SDC0002020-05-23
00819601025103Scott Medical ProductsAnesthesia Calibration GasZ04OX33KSD00002023-03-06
00819601024991Scott Medical ProductsAnesthesia Calibration GasZ02OX86MUD00002023-02-24
00819601025004Scott Medical ProductsAnesthesia Calibration GasZ03OX17MUD00002023-02-24
00819601025011Scott Medical ProductsAnesthesia Calibration GasZ03OX20MUD00012023-02-24
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00819601025035Scott Medical ProductsAnesthesia Calibration GasZ03OX56MUD00002023-02-24
00819601025042Scott Medical ProductsCalibration GasZ02NI854SD00002023-02-24
00819601025059Scott Medical ProductsCalibration GasZ02NI804SD00002023-02-24
00819601025066Scott Medical ProductsCalibration GasZ03NI15415A00002023-02-24
00819601025073Scott Medical ProductsAnesthesia Calibration GasZ04NI70M15A00002023-02-25
00819601025080Scott Medical ProductsCalibration GasZ02NI83415A00012023-02-25
00819601025097Scott Medical ProductsCalibration GasZ02NI99415A00002023-02-25
00819601024960Bionostic, Inc.Calibration GasZ03NI85430000012023-02-17
00819601024977Bionostic, Inc.Calibration GasZ03NI82430000012023-02-17
00819601024984Bionostic, Inc.Calibration GasZ03NI874300Z2352023-02-17
00819601024632Scott Medical ProductsCalibration GasZ02NI978200C0002023-02-11
00819601024649Scott Medical ProductsAnesthesia Calibration GasZ03OX61MUD00012023-02-11
00819601024656Scott Medical ProductsAnesthesia Calibration GasZ03OX69MUD00042023-02-11
00819601024663Scott Medical ProductsAnesthesia Calibration GasZ02AI97MUD00012023-02-11

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