FDA.reportPublic FDA data

Pediatric Cannula

Primary DI
00848530106119
Brand
Pediatric Cannula
Company
Sunset Healthcare Solutions, Inc.
Model
RES1107SPU
Device description
Pediatric Soft Cannula with 7ft. Supply Tube, Universal Connector
Published
2025-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530106119PrimaryGS10
10848530106116Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530106119008485301061198485301061190848530106119
1084853010611610848530106116

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, basicA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
50
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15
00848530109479Nasal CPAP MaskCM060L-NV2026-07-15
00848530109486Nasal CPAP MaskCM060XL-NV2026-07-15
00848530109523Oxygen KitAHOW001O2KIT2026-08-20
00848530109592Ventilator FilterVF010-12026-08-20
00848530109608Ventilator FilterVF010F-12026-08-20
00848530109639Nasal CPAP MaskCM060SNH2026-08-24
00848530109646Nasal CPAP MaskCM060MNH2026-08-24
00848530109653CPAP MaskCM061SNH2026-08-24
00848530109660CPAP MaskCM061MNH2026-08-24
00848530109691CPAP HeadgearHG060B2026-09-09
00848530109721OXYGEN CONNECTOR/ADAPTERRES019-1PL2026-09-09
00848530109738CPAP FilterCF1015NS2026-08-31
00848530109783Oxygen AccessoryPOCBAG-P22026-09-09
00848530109813AerosolTUB100-1FT15MM2026-09-09
00848530109820Ventilation AccessoryVEN008NS2026-09-09
00848530109837Ventilation AccessoryRES096MPNS2026-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118600361Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118607988Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118609616Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118614900Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617338Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617352Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617376Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617390Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617413Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617437Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617895Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620901Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620918Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620925Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620932Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118621052Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
04719874951023Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-21
04719874952471Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-21
04719874950682Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950699Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950705Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950712Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950729Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950736Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874951306Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874951313Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952419Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952426Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952433Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952464Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20