FDA.reportPublic FDA data

Aladin2

Primary DI
00840682123983
Brand
Aladin2
Company
DATEX-OHMEDA INC
Model
SEV CLOSED-FILL
Device description
ALADIN2 SEV CLOSED-FILL P
Published
2018-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K170872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170872000Aisys CS2Datex-Ohmeda, Inc.2017-08-15BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682123983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682123983008406821239838406821239830840682123983

GMDN Terms#

Term, Definition table
TermDefinition
Sevoflurane anaesthesia vaporizerA device used to vaporize the anaesthetic agent sevoflurane 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
129501685
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00840682102353Aestiva GS7900 2 vap art arm2015-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675594956Atlan A100 XLDrägerwerk AG & Co. KGaABSZ2026-08-03
04048675594963Atlan A100Drägerwerk AG & Co. KGaABSZ2026-08-03
00814905021400Codonics Safe Label System®(SLS) 610i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021417Codonics Safe Label System®(SLS) 620i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021455Codonics Safe Label System®(SLS) 700i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEMPARKER-HANNIFIN CORPORATIONBSZ2025-09-24
00810085200130Ultra PC% Oral Surgery Package HACCUTRON, INC.BSZ2025-05-14
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
00852087007881Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00852087007898Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00816711024439DIGITAL MDM ASSY-120V(STAND MTPARKER-HANNIFIN CORPORATIONBSZ2024-04-05
00813830026979FRU, Gauge Newport O2ACCUTRON, INC.BSZ2023-10-05
00813830021141Flowmeter, CMACCUTRON, INC.BSZ2023-09-21
00813830027785Flowmeter, Digital FlushMount, INTACCUTRON, INC.BSZ2023-09-21
04048675556169Atlan A300 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556176Atlan A350Drägerwerk AG & Co. KGaABSZ2023-09-21
04048675556183Atlan A350 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556343Atlan A300Drägerwerk AG & Co. KGaABSZ2023-09-21
00813830026986FRU, Gauge Newport N2OACCUTRON, INC.BSZ2023-09-15
00813830026993FRU, Gauge Newport Int O2ACCUTRON, INC.BSZ2023-09-15
00813830024579Chair Conversion KitACCUTRON, INC.BSZ2023-09-14
00813830023626Ultra PC % Pkg B, InternationalACCUTRON, INC.BSZ2023-09-13
0081383002458656800 Chair Conversion KitACCUTRON, INC.BSZ2023-09-13
00813830027402Ultra PC % Package C ADJSACCUTRON, INC.BSZ2023-09-13
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