FDA.reportPublic FDA data

My Penguin Compressor Nebulizer

Primary DI
00840117300026
Brand
My Penguin Compressor Nebulizer
Company
Dynarex Corporation
Model
5608PN
Published
2019-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043238000COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIESEmg Technology Co., Ltd.2005-07-06CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117300026PrimaryGS10
00616784560847Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117300026008401173000268401173000260840117300026
00616784560847006167845608476167845608470616784560847

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
4
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00616784011011Forearm Crutches - Youth, 4'2" - 5'2"101102019-09-30
00616784011110Forearm Crutches - Adult, 5'0" - 6'2"101112019-09-30
00616784011219Forearm Crutches - Tall, 5'10" - 6'6"101122019-09-30
00616784013114Round Handle Cane with Vinyl Grip101312019-09-30
00616784013213Round Handle Cane with Foam Grip101322019-09-30
00616784013312Offset Cane, Black101332019-09-30
00616784013510T-Handle Folding Cane101352019-09-30
00616784013619Quad Cane Small Base, Black101362019-09-30
00616784013718Quad Cane, Large Base, Black101372019-09-30
00616784013817Bariatric Quad Cane, Large Base101382019-09-30
00840117352339Hypodermic Needle, Non-Safety, 20G, 3/4" needles69802019-05-06
00616784910017CurPro Nylon Suture, Black Monofilament, Nonabsorbable, Synthetic91002016-09-24
00616784910116CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91012016-09-24
00616784910215CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91022016-09-24
00616784910314CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91032016-09-24
00616784910413CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91042016-09-24
00616784910611CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91062016-09-24
00616784910710CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91072016-09-24
00616784913018Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet, Braided91302016-09-24

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