FDA.reportPublic FDA data

CPAP Tube 6 ft

Primary DI
00848530103859
Brand
CPAP Tube 6 ft
Company
Sunset Healthcare Solutions, Inc.
Model
TUB006LA
Device description
Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with 22mm Cuffs Gray - For Sale in Latin America
Published
2024-05-23
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
false

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530103859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530103859008485301038598485301038590848530103859

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

Regulatory Flags#

DUNS number
141668116
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530093686Oxygen, Bacteria & HEPA FilterBF40002026-10-19
00848530109790Ventilator FilterVF015-12026-10-19
00848530109929Nebulizer and CompressorACTFISH2026-10-19
00848530109936Nebulizer and CompressorACTBEAR2026-10-19
00848530110031Ventilator FilterVF010-502026-10-19
00084853011017CPAP FilterCF1010F-502026-10-14
00848530109745CPAP FilterCF1015-42026-10-14
00848530109844CPAP FilterCF1015-6PL2026-10-14
00848530110024Oxygen KitADAPTO2SFTKIT2026-10-14
00848530110048Ventilator FilterVF010F-502026-10-14
00848530108885Breathing CircuitVC1002-R2026-10-12
00848530108892Breathing CircuitVC1002P-R2026-10-12
00848530109882CPAP FilterCF2111HA-10PL2026-09-30
00848530109899CPAP FilterCF2107HA-10PL2026-09-30
00848530109905Oxygen KitRESO2KITAZPL2026-09-30
00848530109912Nebulizer and CompressorACTNEB1002026-09-30
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15

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