FDA.reportPublic FDA data

HUDSON RCI

Primary DI
04026704598069
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN045201
Catalog number
780-17
Device description
Universal Neonatal Ventilator Circuit Single Heated Limb with 12-in. Remote Temperature Port (21-volt)
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903083000NEONATAL VENTILATOR CIRCUITHudson Respiratory Care, Inc.1990-12-27BZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704598063PackageGS120In Commercial Distribution
04026704598069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670459806324026704598063
04026704598069040267045980694026704598069

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10801902161335ARROWIPN915831AI-071342020-01-27
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10801902172508ARROWIPN917417CS-24306-E2022-11-29
10801902180268ARROWIPN917220AI-071212021-08-19
10801902180589ARROWIPN918510CS-12702-E2022-11-29
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Primary DI, Brand, Company table
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