FDA.reportPublic FDA data

Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Maximum Neck Size 19.5"/50 cm

Primary DI
00840117319271
Brand
Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Maximum Neck Size 19.5"/50 cm
Company
Dynarex Corporation
Model
35029
Device description
Adult, Large
Published
2022-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CBHDevice, Fixation, Tracheal Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117319110PackageGS110In Commercial Distribution
00840117319196PackageGS15In Commercial Distribution
00840117319271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117319110008401173191108401173191100840117319110
00840117319196008401173191968401173191960840117319196
00840117319271008401173192718401173192710840117319271

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
true
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
00840117349506DynaCare Maxi Pads, Super with Wings1358BG2026-04-24
00840117324008Resp-O2 Compressor, 50 PSI339522022-07-11
00840117348707dmecare Solutions Elongated Folding Bedside Commode, With Collapsible Bucket10373C2026-10-30
00840117310346Resp-O2 Oxygen Cylinder Cart, Single366202026-10-28
00840117310353Resp-O2 Oxygen Cylinder Cart, Dual366212026-10-28
00840117310360Resp-O2 Oxygen Cylinder Holder, Wheelchair Mount366222026-10-28
00840117310278Resp-O2 Oxygen Cylinder Wrenches, Black366002026-10-26
00840117346222Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Post Valve, 4.55 L36390-PBULK2026-10-26
00840117322547Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363702026-10-23
00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363712026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
00840117348684dmecare Solutions Folding Bedside Commode, With Collapsible Bucket10372C2026-10-23
00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
00840117339088Durma+ Transparent Film Dressing, Frame Style36482024-12-13
00616784319438Compress Bandages, Offset, Sterile31942021-06-21
00840117307360Child Face Masks2207-CHCR2021-06-21
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01

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