FDA.report

Inca

Primary DI
20888937009525
Brand
Inca
Company
Coopersurgical, Inc.
Model
44-0715
Device description
Replacement Set 15F
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications

CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions

SubmissionSupplement
K911780000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K911780000INFANT NASAL CANNULAE ASSEMBLY, MODIFIEDAckrad Laboratories1991-06-24BZD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888937009525PackageGS15In Commercial Distribution
60888937009523PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
801895244
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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