FDA.report

Resp-O2 Tracheostomy Drain Sponges

Primary DI
00840117322646
Brand
Resp-O2 Tracheostomy Drain Sponges
Company
DYNAREX CORPORATION
Model
35050
Device description
Resp-O2 Tracheostomy Drain Sponges, Non-Woven, Sterile, 4" x 4", 6-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

Related Records

Product Codes

CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117309821PackageGS125In Commercial Distribution
00840117309838PackageGS112In Commercial Distribution
00840117312340PrimaryGS10
00840117322646Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117309821008401173098218401173098210840117309821
00840117309838008401173098388401173098380840117309838
00840117312340008401173123408401173123400840117312340
00840117322646008401173226468401173226460840117322646

GMDN Terms

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

Regulatory Flags

DUNS number
008124539
Device count
2
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

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