FDA.reportPublic FDA data

HUDSON RCI

Primary DI
24026704648171
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049764
Catalog number
1080
Device description
Mask, Aerosol, Pediatric
Published
2019-05-09
Public version status
New
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
BYGMASK, OXYGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704648171PackageGS150In Commercial Distribution
04026704594337PreviousGS10
14026704648174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670464817124026704648171
04026704594337040267045943374026704594337
1402670464817414026704648174

GMDN Terms#

Term, Definition table
TermDefinition
Aerosol face mask, rebreathingA flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device.

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
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011612HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344009626HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
08697645018112ENDURE INDUSTRIESENDURE INDUSTRIESBYG2025-10-16
14026704648150HUDSON RCITELEFLEX INCORPORATEDBYG2025-07-03
14026704648235HUDSON RCITELEFLEX INCORPORATEDBYG2025-07-03