FDA.reportPublic FDA data

HUDSON RCI

Primary DI
14026704659873
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN913784
Catalog number
780-02
Device description
Universal Neonatal Ventilator Circuit Single Heated Limb with Remote Temperature Port
Published
2019-05-09
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
24026704659870PackageGS120In Commercial Distribution
14026704659873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670465987024026704659870
1402670465987314026704659873

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902213188ARROWIPN927188DLX-200-CURV2026-07-23
10841156108908TRAPLINERIPN91750955672026-07-23
10841156111311LANGSTONIPN93013555402026-07-23
14026704944450RUSCH2205000602205000602026-07-23
14026704945402RUSCH2204001402204001402026-07-23
14026704945419RUSCH2204001602204001602026-07-23
14026704945426RUSCH2205000802205000802026-07-23
14026704945617RUSCH2204000802204000802026-07-23
14026704945624RUSCH2204001002204001002026-07-23
14026704945846RUSCH2214000602214000602026-07-23
20801902193548ARROWIPN920133CS-15362-SPM2026-07-23
20801902193593ARROWIPN920138CS-15192-VF2026-07-23
14026704927453GIBECKIPN929805133122025-07-31
10801902226485ARROWIPNB00690ASK-21242-CWH12026-07-22
14026704624697RUSCHIPN04946312241102026-07-22
14026704911810PLEUR-EVACIPN927045S-1150-08LF2026-07-22
30801902193538ARROWIPN920132CS-15322-SPM2026-07-22
10841495149471QUIKCLOT1881882026-07-17
14026704645333WECKIPN9142504200232026-07-21
14026704714510LMA ATOMIZATIONIPN916119MAD300B2026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874950637Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874950644Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874950651Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874951139Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874951146Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874957483Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874957919Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959128Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959487Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959494Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959500Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959517Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959524Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
09420012402691Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
09420012433756Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
10197344011346HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011353HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
09420012479105F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479129F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479143F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479167F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
10889483225653AirLife™SUNMED, LLCBZO2025-12-19
09420012414885AdaptorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2025-10-07
14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
10889483570555AirLife™AIRLIFEBZO2025-03-27
10889483571675AirLife™AIRLIFEBZO2025-03-27
10889483571682AirLife™AIRLIFEBZO2025-03-27
10889483571699AirLife™AIRLIFEBZO2025-03-27