FDA.reportPublic FDA data

Large Infant CPAP Nasal Cannula Only

Primary DI
10858409005228
Brand
Large Infant CPAP Nasal Cannula Only
Company
Medicomp
Model
MC-1003
Catalog number
MC-1003
Published
2017-09-11
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

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
10858409005228PackageGS112In Commercial Distribution
00858409005221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085840900522810858409005228
00858409005221008584090052218584090052210858409005221

GMDN Terms#

Term, Definition table
TermDefinition
CPAP nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154454730
Device count
1
DM exempt
false
Premarket exempt
false
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
00858409005009Adult Bacterial/Viral FilterMC-500MC-5002016-09-26
00858409005269Small/Medium CPAP Cap OnlyMC-1111MC-11112017-09-11
00858409005276Large CPAP Cap OnlyMC-1212MC-12122017-09-11
00858409005436Small/Medium CPAP Cap Only MC-1111SSMC-1111SS2017-09-11
00858409005443Large CPAP Cap OnlyMC-1212SSMC-1212SS2017-09-11
00858409005016Infant Bacterial/Viral FilterMC-125MC-1252017-09-11
00858409005399Metered Dose ElbowMC-1423MC-14232017-09-11
00858409005405Metered Dose Straight SwivelMC-1523MC-15232017-09-11
00858409005023Nebulizer Bacteria FilterMC-350MC-3502017-09-11
00858409005030Spirometer Bacterial/Viral FilterMC-850MC-8502017-09-11
00858409005290Bronchoscopy Suction Swivel AdapterMC-3125MC-31252017-09-11
00858409005337Dual Swivel ElbowMC-4450MC-44502017-09-15
00858409005344Dual Swivel Elbow with Suction PortMC-4475MC-44752017-09-15
00858409005351Single Straight Swivel ConnectorMC-4490MC-44902017-09-15
00858409005368Adult Bacterial/Viral Filter with C02 PortMC-555XMC-555X2017-09-11
00858409005450"Dual Swivel Elbow, 6"" Expandable Tubing"MC-5450MC-54502017-09-15
00858409005467"Dual Swivel Elbow, 6"" Expandable Tubing with 22F Connector"MC-5460MC-54602017-09-15
00858409005474"Dual Swivel Elbow with Suction Port, 6"" Expandable Tubing"MC-5475MC-54752017-09-15
00858409005481"Dual Swivel Elbow with Suction Port, 6"" Expandable Tubing with 22F Connector"MC-5480MC-54802017-09-15
00858409005498"Single Straight Swivel Connector, 6"" Expandable Tubing"MC-5490MC-54902017-09-15

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Primary DI, Brand, Company table
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