FDA.reportPublic FDA data

HUDSON RCI

Primary DI
34026704662358
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN039374
Catalog number
51023
Device description
REPLACEMENT PARTRESERVOIR VALVE
Published
2019-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895589000MANUAL RESUSCITATORHudson Oxygen Therapy Sales Co.1990-03-30BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704662358PackageGS150In Commercial Distribution
24026704662351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670466235834026704662358
2402670466235124026704662351

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia workstation yoke assemblyA device that is a module to an anaesthesia workstation and functions as a mounting system used to attach compressed gas cylinders to the anaesthesia system. The yoke assembly typically includes a filter, pressure regulator, pressure relief valve, and pressure indicator, or gas-specific pin-index connecting system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees 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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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10801902222937ARROWIPN931155CV-158022026-05-20
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10841156105907VSIIPN00174679602020-01-27
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10841156105921VSIIPN00175279622020-02-06
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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

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Primary DI, Brand, Company table
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