FDA.reportPublic FDA data

HUDSON RCI

Primary DI
14026704390141
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN044433
Catalog number
41635
Device description
DISPOSABLE THERMOMETER,INTL
Published
2018-11-07
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQZTHERMOMETER, CLINICAL COLOR CHANGE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQZThermometer, Clinical Color ChangeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14026704390141PackageGS150Not in Commercial Distribution
34026704390145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1402670439014114026704390141
3402670439014534026704390145

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory gas thermometerA non-sterile device intended to measure the temperature of respiratory gases prior to entering a patient’s airway to help manage patient comfort and facilitate therapeutic compliance. It is a slender, hollow glass tube with a bulb at the base that is filled with coloured alcohol whereby temperature is measured based on the capillary principle. It is intended to be inserted into a compatible temperature monitor port of a breathing circuit connecter (e.g., Y-piece connecter); it may be used in the home or healthcare facility. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

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Primary DI, Brand, Company table
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10016944701085TraxItMEDICAL INDICATORS INCFQZ2025-05-08
10889483570869AirLife™AIRLIFEFQZ2025-03-27
10889483570883AirLife™AIRLIFEFQZ2025-03-27
30889483570863AirLife™Sunmed Group Holdings, LLCFQZ2025-03-27
30889483570887AirLife™Sunmed Group Holdings, LLCFQZ2025-03-27
10889483570876AirLife™AIRLIFEFQZ2025-03-06
30889483570870AirLife™Sunmed Group Holdings, LLCFQZ2025-03-06
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00016944401438 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
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20016944401425NexTempMEDICAL INDICATORS INCFQZ2023-11-17
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10190752157637AirLife™VYAIRE MEDICAL, INC.FQZ2022-08-22
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00016944401346NexTempMEDICAL INDICATORS INCFQZ2021-08-30
00016944401322NexTempMEDICAL INDICATORS INCFQZ2021-08-12
00016944401339NexTempMEDICAL INDICATORS INCFQZ2021-08-12
10016944401114NexTempMEDICAL INDICATORS INCFQZ2021-08-12