FDA.reportPublic FDA data

Resp-O2 Tracheostomy Gauze Sponges

Primary DI
00840117322653
Brand
Resp-O2 Tracheostomy Gauze Sponges
Company
DYNAREX CORPORATION
Model
35051
Device description
Resp-O2 Tracheostomy Gauze Sponges, Sterile, 100% Cotton, 4" x 4", 12-Ply, 2 per pouch
Published
2022-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117309852PackageGS16In Commercial Distribution
00840117340251PackageGS150In Commercial Distribution
00840117309845PrimaryGS10
00840117340244PrimaryGS10
00840117322653Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117309852008401173098528401173098520840117309852
00840117340251008401173402518401173402510840117340251
00840117309845008401173098458401173098450840117309845
00840117340244008401173402448401173402440840117340244
00840117322653008401173226538401173226530840117322653

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube dressingA pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
50
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22
00840117311572Resp-O2 Oxygen Supply Tubing332022021-04-22
00840117311596Resp-O2 Oxygen Supply Tubing332032021-04-22
00840117311619Resp-O2 Oxygen Supply Tubing332042021-04-22
00840117311633Resp-O2 Oxygen Supply Tubing332052021-04-22
00840117311657Resp-O2 Oxygen Supply Tubing332062021-04-22
00840117311671Resp-O2 Oxygen Supply Tubing332072021-04-22
00840117311695Resp-O2 Oxygen Supply Tubing332082021-04-22
00840117318625Resp-O2 Oxygen Tubing Inline Water Traps333022021-04-22
00840117318632Resp-O2 Oxygen Tubing 22mm I.D. x 5-7 mm Tapered Nipple Adaptors333032021-04-22
00840117318649Resp-O2 Oxygen Tubing 5-7 mm End Adaptors333042021-04-22
00840117318663Resp-O2 Oxygen Tubing Y Adaptors333062021-04-22
00840117318670Resp-O2 Oxygen Tubing Nut Nipple Adaptors333072021-04-22
00840117318687Resp-O2 Oxygen Tubing Nut Nipple Swivel Adaptors333082021-04-22
00840117318694Resp-O2 Portable Oxygen Liter Meters333092021-04-22
00840117342361Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) O2 and CO2 Tubing331982025-06-09
00840117342408Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) O2 and CO233199-F2025-06-09
00840117324008Resp-O2 Compressor, 50 PSI339522022-07-11
00840117310254Resp-O2 Oxygen Concentrator, 5L339502022-05-10

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