FDA.reportPublic FDA data

Resp-O2 Tracheostomy Mask

Primary DI
00840117318038
Brand
Resp-O2 Tracheostomy Mask
Company
DYNAREX CORPORATION
Model
34022
Device description
Resp-O2 Tracheostomy Pediatric Mask with Swivel Tubing Connector, One Side Snap
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117318038PackageGS150In Commercial Distribution
00840117318014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117318038008401173180388401173180380840117318038
00840117318014008401173180148401173180140840117318014

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy mask, oxygenA device designed to deliver oxygen or a mixture of oxygen and air to a patient who has a tracheostomy airway. It is connected to an oxygen/medical air source with tubing and is constructed of plastic. The device can be used over a tracheal tube or stoma. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784124810Transducer Covers, For Ultrasound Imaging Systems, 5.3 cm x 20 cm12482016-09-24
00616784426211Piston Irrigation Syringe,Ring Top Syringe with Protective Cap Tubing Adaptor42622021-09-01
00616784020518Vivid-Essential Rollator with 6" Casters, Red102052019-10-07
00616784020617Vivid-Essential Rollator with 6" Casters, Blue102062019-10-07
00616784703015"IV Administration Set, 10 mL, Non-Toxic, 83"" "70302016-09-24
00616784703312"IV Administration Set, Non-Toxic, 15 mL, 106"" (269.2 cm)"70332016-09-24
00616784703411"IV Administration Set, 15 mL, Non-Toxic, 73"" (185.4 cm)"70342016-09-24
00616784703718"IV Administration Set, 15 mL, Non-Toxic, 15-Drops /mL, 92"" (234.7 cm)"70372016-09-24
00616784704814"IV Administration Set, 20 mL, Non-Toxic, 20-Drops/mL, 100"" (254.0 cm) "70482016-09-24
00616784704913"IV Administration Set, 20 mL, Non-Toxic, 92"" (233.7 cm)"70492016-09-24
00616784705118"IV Administration Set, 60 mL, Non-Toxic, 60-Drops/ mL, 83"" (210.8 cm) "70512016-09-24
00616784705217"IV Administration Set, 60 mL, Non-Toxic, 60-Drops/mL, 78"" (198.1 cm) "70522016-09-24
00616784705415Needleless PRN Luer Connectors, Non-Toxic70542016-09-24
00840117334502Pre-Filled Saline Flush Syringe, 5 mL70582024-03-07

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