FDA.reportPublic FDA data

ARROW

Primary DI
20801902179368
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN919009
Catalog number
IAH-09048
Device description
HELIUM: HZL 105 LITER 22 16 PS
Published
2021-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSPSystem, balloon, intra-aortic and control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSPSystem, Balloon, Intra-Aortic And ControlCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060309000AUTOCAT INTRA-AORTIC BALLOON PUMP SERIESArrow Intl., Inc.2006-04-06DSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902179368PackageGS11In Commercial Distribution
10801902179361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190217936820801902179368
1080190217936110801902179361

GMDN Terms#

Term, Definition table
TermDefinition
Medical air refillable cylinderA container designed as a refillable cylinder used to hold compressed medical air [a mixture of approximately 21% oxygen (O2) and 78% nitrogen (N2) and other inert gases] under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with medical air when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote medical air content. The cylinder is typically made of steel and must be used together with a pressure regulator in order to release the air at the correct working pressure. Medical air is used for life support, therapeutic purposes and in anaesthesia.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature052 Degrees Celsius
Special Storage Condition, Specify00Store between -15 Celsius and 40 Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902223859ARROWTELEFLEX INCORPORATEDDSP2025-10-02
10801902219609ARROWTELEFLEX INCORPORATEDDSP2025-04-30
20801902219606ARROWTELEFLEX INCORPORATEDDSP2025-04-30
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10607567113449CARDIOSAVE RESCUE, 3.1 EDITIONDatascope Corp.DSP2024-09-09
10607567114187"CARDIOSAVE HYBRID - TYPE ""N"" PLUG"Datascope Corp.DSP2024-09-09
10607567107585YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KITDATASCOPE CORP.DSP2024-08-12
10607567107592YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)DATASCOPE CORP.DSP2024-08-12
10607567107608YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KITDATASCOPE CORP.DSP2024-08-12
10607567107639YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)DATASCOPE CORP.DSP2024-08-12
10607567111537Catheter Extender for Yamato Plus IABs - 10 PackDATASCOPE CORP.DSP2024-08-12
10607567111711TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIESDATASCOPE CORP.DSP2024-08-12
10607567111728TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIESDATASCOPE CORP.DSP2024-08-12
10607567104713CABLE,EXTERNAL SIGNAL,IABPDatascope Corp.DSP2024-07-26
10607567112817CARDIOSAVE LI-ION SINGLE BTTY TRANSPORTDatascope Corp.DSP2024-07-26
10607567113760CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCEDatascope Corp.DSP2024-07-26
10607567113777CABLE,LOW LEVEL OUTPUT,PHILIPSDatascope Corp.DSP2024-07-26
10607567113784CABLE,LOW LEVEL OUTPUT,GEDatascope Corp.DSP2024-07-26
10607567113807"CABLE,INTERFACE,1/4-1/4"",30'"Datascope Corp.DSP2024-07-26
10607567113814"CABLE, INTERFACE .25"" PLUG TO .25"" PLUG 30"Datascope Corp.DSP2024-07-26
10607567113821CABLE, INTERFACE 1/4” PLUG TO 1/8” PLUG,Datascope Corp.DSP2024-07-26
10607567113845CABLE INTERFACE 1/4” BIFURCATED PLUGS TO 6Datascope Corp.DSP2024-07-26
10607567113852"CABLE INTERFACE, 1/4"" PLUG TO TT-253 PLU"Datascope Corp.DSP2024-07-26
10607567113869AC PWR CORD,NEMA 5-15P TYPE BDatascope Corp.DSP2024-07-26
10607567113975COVER,CARDIOSAVE RAINDatascope Corp.DSP2024-07-26
10607567114262CABLE,LOW LEV OUTPUT,DATASCOPEDatascope Corp.DSP2024-07-26
10607567114279CABLE,LL OUTPUT,UN-TERMINATEDDatascope Corp.DSP2024-07-26
10801902218909ARROWTELEFLEX INCORPORATEDDSP2024-04-29
10801902218916ARROWTELEFLEX INCORPORATEDDSP2024-04-29