FDA.report

HUDSON RCI

Primary DI
34026704662327
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN039371
Catalog number
51020
Device description
REPLACEMENT PART RESERVOIR VALVEHOUSING
Published
2020-06-08
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

Related Records

Contact Domains

Product Codes

CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704662327PackageGS1100In Commercial Distribution
14026704662323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670466232734026704662327
1402670466232314026704662323

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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