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
00840682119320Well Baby BassinetBN42016-07-29
00840682119337Well Baby BassinetBN72016-07-29
00840682119344Well Baby BassinetBN32016-07-29
00840682119375Well Baby BassinetBN12016-07-29
00840682119399Well Baby BassinetBN22016-07-29
00840682119429Well Baby BassinetBN62016-07-29
00840682119436Well Baby BassinetBN92016-07-29
00840682119467Well Baby BassinetBN82016-07-29
00840682119481Well Baby BassinetBN102016-07-29
00840682119498Well Baby BassinetBN52016-07-29
00840682102353Aestiva GS7900 2 vap art arm2015-09-23
00840682102261Aespire79002015-09-23
00840682102285AespireView2015-09-23
00840682102308Aestiva79002015-09-23
00840682102339AestivaMRI2015-09-23
00840682102360Aestiva GS7900 3 vap art arm2015-09-23
00840682146425Carestation 750cA12023-04-04
00195278579157ET CONTROL OPTIONAISYS CS22022-07-21
00195278588128AisysCS2 WITH ET CONTROL2022-07-21
00840682102322AvanceCS22015-09-23

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Primary DI, Brand, Company table
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B510AM60001ADVANCED GAS-MACHINE ANESTHESIAADVANCED INSTRUMENTATIONS, INC.BSZ2025-02-07
05051977000857PenlonPENLON LTDBSZ2024-12-06
06936415980702A3 Anesthesia Delivery SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.BSZ2024-11-20
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04048675556343Atlan A300Drägerwerk AG & Co. KGaABSZ2023-09-21
00813830026986FRU, Gauge Newport N2OACCUTRON, INC.BSZ2023-09-15
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00813830027419Ultra DC Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027426Digital Ultra Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027709Digital Ultra Flushmount Package G, INTACCUTRON, INC.BSZ2023-09-13
00813830028195Digital Ultra Package C, InternationalACCUTRON, INC.BSZ2023-09-13
00813830028522Digital Ultra Package F, UKACCUTRON, INC.BSZ2023-09-13