FDA.reportPublic FDA data

KC Airway Taping System

Primary DI
00860009651609
Brand
KC Airway Taping System
Company
KelCor, LLC
Model
KTST-103001
Device description
Adult Airway Tape and Eye Tape - Short-term
Published
2023-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBHDevice, Fixation, Tracheal Tube
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009651609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009651609008600096516098600096516090860009651609

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical skin adhesive tapeA long thin band of synthetic material coated on one side with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or combination of materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
901-300-6125info@kelcortape.com

Regulatory Flags#

DUNS number
081476206
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009651616KC Eye TapeEYST-3000202023-07-27
00860009651630KC Airway Tape - Long-termAWLT-2000012026-01-22
00860009651623KC Airway TapeAWST-1000012025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
08904428744947OSSEOUS- NeckFit Tube HolderEON MEDITECH PRIVATE LIMITEDCBH2026-03-13
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
10192253044591ArgyleCardinal Health 200, LLCCBH2025-08-26
10889483605141AirLife™AIRLIFECBH2025-03-18
10889483605134AirLife™AIRLIFECBH2025-03-13
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
10197344103607MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103614MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103621MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103638MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103645MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103652MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10618125191625PoseyTIDI PRODUCTS, LLCCBH2024-05-03
10618125191670PoseyTIDI PRODUCTS, LLCCBH2024-05-03
10840330703410ProCureTwin Med, LLCCBH2024-02-23
10840330703908ProCureTwin Med, LLCCBH2024-02-23
10840330703915ProCureTwin Med, LLCCBH2024-02-23
10840330703922ProCureTwin Med, LLCCBH2024-02-23
08052276029638Eye Shield AKTIVE SRLHOY2024-01-15
10850014574717Trach TiePEPPER MEDICAL INC.CBH2023-10-25
10850014574724Trach TiePEPPER MEDICAL INC.CBH2023-10-25
10850014574731Vent TiePEPPER MEDICAL INC.CBH2023-10-25
10850014574748Vent TiePEPPER MEDICAL INC.CBH2023-10-25
10810141931043VIVIT SupplyVivit Supply LLCHOY2023-09-15
10810141931050VIVIT SupplyVivit Supply LLCHOY2023-09-15
10810141931067VIVIT SupplyVivit Supply LLCHOY2023-09-15
10812594011464EZCare™ SoftouchNeotech Products LLCCBH2023-09-08