FDA.reportPublic FDA data

COMFIT

Primary DI
20888937016646
Brand
COMFIT
Company
Coopersurgical, Inc.
Model
42-1820
Device description
COMFIT Endotracheal Tube Holder
Published
2022-10-30
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
true

Product Codes#

Code, Name table
CodeName
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937016646PackageGS125In Commercial Distribution
30888937016643PackageGS14In Commercial Distribution
00888937016642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701664620888937016646
3088893701664330888937016643
00888937016642008889370166428889370166420888937016642

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube holderA device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
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
true
Expiration date on label
true
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
60888937029798ORIGIO Gradient 90 w/o Gentamicin 84905060D2026-03-12
00888937028331ORIGIO Sequential Blast83050010M2026-02-05
00888937028348ORIGIO Sequential Blast83050060M2026-02-05
00888937028355ORIGIO Sequential Blast83060010M2026-02-05
00888937028386ORIGIO Sequential Cleav83030010M2026-02-05
00888937028393ORIGIO Sequential Cleav83030060M2026-02-05
00888937028409ORIGIO Sequential Cleav83040010M2026-02-05
00888937028416ORIGIO Sequential Cleav83040060M2026-02-05
00888937028430ORIGIO Sequential Fert83010010M2026-02-05
00888937028447ORIGIO Sequential Fert83010060M2026-02-05
00888937028454ORIGIO Sequential Fert83020010M2026-02-05
00888937028461ORIGIO Sequential Fert83020060M2026-02-05
00888937028607SynVitro Flush15840125M2026-02-05
00888937028959Origio Handling83100060M83102026-02-05
00888937028966Origio Handling83100125M83102026-02-05
00888937028973Origio Handling83110060M83112026-02-05
00888937028980Origio Handling83110125M83112026-02-05
00888937029116SAGE 1-Step67010010M2026-02-05
00888937029123SAGE 1-Step67010060M2026-02-05
60888937029330ORIGIO Sperm Wash84050060M2026-02-05

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Primary DI, Brand, Company table
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10889483225455Septal-H™SUNMED, LLCJAY2025-12-15
10889483226506AirLife™SUNMED, LLCJAY2025-12-15
10889483226513AirLife™SUNMED, LLCJAY2025-12-15
10889483228586Capette™SUNMED, LLCJAY2025-12-15
10889483228593Capette™SUNMED, LLCJAY2025-12-15
10889483228609Strapette™SUNMED, LLCJAY2025-12-15
10889483228616Strapette™SUNMED, LLCJAY2025-12-15
10889483228623Capette™SUNMED, LLCJAY2025-12-15
10889483228630Capette™SUNMED, LLCJAY2025-12-15
10889483228647Capette™SUNMED, LLCJAY2025-12-15
10889483228654Strapette™SUNMED, LLCJAY2025-12-15
10889483228661Strapette™SUNMED, LLCJAY2025-12-15
10889483228692SavEar™ SUNMED, LLCJAY2025-12-15
10889483230244AirLife™SUNMED, LLCJAY2025-12-15
00653658009019Marpac IncMarpac, Inc.JAY2025-06-06
00850014574604PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
00860013561406MPVMovair, Inc.JAY2025-03-12
00860013561413MPVMovair, Inc.JAY2025-03-12
00860010190845AcanthusAcanthus Medical Creations LLCJAY2024-12-13
00860010190852AcanthusAcanthus Medical Creations LLCJAY2024-12-13
04250105611465Anesthetic Tube Holder with 3-Joint-SystemVBM Medizintechnik GmbHJAY2024-06-25
04250105611472Pressure Transducer HolderVBM Medizintechnik GmbHJAY2024-06-25
04250105611489Anesthetic Tube Holder with 3-Joint-SystemVBM Medizintechnik GmbHJAY2024-06-25
04250105611427Anesthetic Tube Holder with 3-Joint-SystemVBM Medizintechnik GmbHJAY2024-06-20
10080196150090MedlineMEDLINE INDUSTRIES, INC.JAY2024-03-27
10850014574809Endo TiePEPPER MEDICAL INC.JAY2023-10-25