FDA.reportPublic FDA data

KONLIDA

Primary DI
16974600043594
Brand
KONLIDA
Company
Suzhou Konlida Medical Supplies Co., Ltd.
Model
Type L 7cm*10cm
Published
2025-07-28
Public version status
New
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
16974600043594PackageGS1300In Commercial Distribution
26974600043591PackageGS16In Commercial Distribution
06974600043597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697460004359416974600043594
2697460004359126974600043591
06974600043597069746000435976974600043597

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holderA device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
711198330
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974600043566KONLIDAType A 3cm*9cm2025-07-28
06974600043573KONLIDAType C 6cm*11cm2025-07-28
06974600043580KONLIDAType I 50cm2025-07-28
06974600043597KONLIDAType L 7cm*10cm2025-07-28
06974600043603KONLIDAType R 3cm*8cm2025-07-28
06974600043610KONLIDAType T 6cm*7cm2025-07-25
16974600043624KONLIDAA01 1.25cm*9m2025-07-28
16974600043631KONLIDAA02 2.5cm*9m2025-07-28
16974600043648KONLIDAB01 1.25cm*9m2025-07-28
16974600043655KONLIDAB02 2.5cm*9m2025-07-28
06974600043207KONLIDAA01BLK 1 strap/pc2025-07-28
06974600043214KONLIDAA02BLK 2 straps/pc2025-07-28
06974600043221KONLIDAA03BLK 3 straps/pc2025-07-28
06974600043238KONLIDAA04BLK 5 straps/pc2025-07-28
06974600043245KONLIDAA05BLK 3-strap/pc2025-07-28
06974600043252KONLIDAA06BLK 5-strap/pc2025-07-28
06974600043269KONLIDAA07BLK 7-strap/pc2025-07-28
06974600043276KONLIDAB01FLK 1 strap/pc2025-07-28
06974600043283KONLIDAB02FLK 2 straps/pc2025-07-28
06974600043290KONLIDAB03FLK 3 straps/pc2025-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428744947OSSEOUS- NeckFit Tube HolderEON MEDITECH PRIVATE LIMITEDCBH2026-03-13
00612479280571McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280601McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280632McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280663McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
10192253044591ArgyleCardinal Health 200, LLCCBH2025-08-26
00848530105853Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
10889483605141AirLife™AIRLIFECBH2025-03-18
10889483605134AirLife™AIRLIFECBH2025-03-13
00610075095834AnchorFast SlimFitHOLLISTER INCORPORATEDCBH2024-11-05
00610075095766AnchorFastHOLLISTER INCORPORATEDCBH2024-10-03
00610075095780AnchorFast GuardHOLLISTER INCORPORATEDCBH2024-09-03
00610075095810AnchorFast Guard SelectHOLLISTER INCORPORATEDCBH2024-09-03
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
00848530103514One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103521One Piece Tracheostomy Tie Pediatric 2.5cm x 30cm (11.5in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103538Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103545Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103552Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103569Two Piece Tracheostomy Tie Pediatric 2cm x 45.5cm (18in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
10840330703410ProCureTwin Med, LLCCBH2024-02-23
10840330703908ProCureTwin Med, LLCCBH2024-02-23
10840330703915ProCureTwin Med, LLCCBH2024-02-23