FDA.reportPublic FDA data

Dynarex My Resp-O2 Doggy Compressor Nebulizer

Primary DI
00840117308763
Brand
Dynarex My Resp-O2 Doggy Compressor Nebulizer
Company
DYNAREX CORPORATION
Model
34403
Published
2021-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00840117308763PackageGS14In Commercial Distribution
00840117308756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117308763008401173087638401173087630840117308763
00840117308756008401173087568401173087560840117308756

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
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00840117304086Stand Up Cane, Black101392021-09-01
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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