FDA.reportPublic FDA data

Carestation 750

Primary DI
00840682145596
Brand
Carestation 750
Company
DATEX-OHMEDA INC
Model
A1
Device description
CARESTATION 750 A1
Published
2023-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BSZGas-machine, anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSZGas-Machine, AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213867000Carestation 750/750cDatex-Ohmeda, Inc.2023-03-28BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682145596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682145596008406821455968406821455960840682145596

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia workstation, general-purposeAn assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure67 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129501685
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682103947Carestation 650A12016-02-12
00840682103954Carestation 650cA12016-02-12
00840682103985Carestation 620A12016-02-12
00840682111317TEC 7VAP SEV 8% EASY-FIL EN2016-06-01
00840682111324TEC 7VAP HAL 5% EASY-FIL ES LATIN AMERICA2016-06-01
00840682111508TEC 7VAP SEV 8% EASY-FIL ES LATIN AMERICA2016-06-01
00840682111614TEC 7VAP SEV 8% EASY-FIL EN A12016-06-01
00840682111751TEC 7VAP SEV 8% QUIK-FIL EN2016-06-01
00840682112659TEC 6 PLUSVAP DES 220/240V EN2016-06-01
00840682123983Aladin2SEV CLOSED-FILL2018-02-27
00840682123990Aladin2SEV CLOSED-FILL2018-02-15
00840682124720TEC820 SEV2018-03-12
00840682124737TEC850 SEV2018-03-12
00840682124744TEC820 ISO2018-03-12
00840682124751TEC850 ISO2018-03-12
00840682134880NAABS ABSORBENT CANISTER REUSABLE2018-01-18
00840682111300TEC 7VAP ISO 5% EASY-FIL EN2016-06-01
00840682111003TEC 7VAP HAL 5% EASY-FIL EN2016-06-01
00840682111393TEC 7VAP ISO 5% EASY-FIL ES LATIN AMERICA2016-06-01
00840682100274Aladin2ENF EASY-FIL2015-09-23

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Primary DI, Brand, Company table
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B510AM60001ADVANCED GAS-MACHINE ANESTHESIAADVANCED INSTRUMENTATIONS, INC.BSZ2025-02-07
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04048675556183Atlan A350 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556343Atlan A300Drägerwerk AG & Co. KGaABSZ2023-09-21
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