FDA.reportPublic FDA data

Halyard

Primary DI
30680651385254
Brand
Halyard
Company
O&M HALYARD, INC.
Model
38525
Catalog number
38525
Device description
TUBE-CONTROL PLUS with Hydrogel
Published
2023-07-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCYCATHETER, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCYCatheter, InfusionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651385254PackageGS14In Commercial Distribution
10680651385250PrimaryGS10
90680651385256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065138525430680651385254
1068065138525010680651385250
9068065138525690680651385256

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

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
081057389
Device count
25
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
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
30680651501272Halyard50127NS50127NS2026-06-08
30680651501289Halyard50128NS50128NS2026-06-08
30680651501296Halyard50129NS50129NS2026-06-08
30680651501302Halyard50130NS50130NS2026-06-08
10680651497571Halyard49757497572026-06-06
10680651497588Halyard49758497582026-06-06
10680651497595Halyard49759497592026-06-06
20680651500674Halyard50067500672026-06-04
20680651500681Halyard50068500682026-06-04
20680651500698Halyard50069500692026-06-04
20680651500704Halyard50070500702026-06-04
20680651500711Halyard50071500712026-06-04
20680651502388Halyard50238502382026-06-04
20680651502395Halyard50239502392026-06-04
20680651502401Halyard50240502402026-06-04
20680651502418Halyard50241502412026-06-04
20680651502425Halyard50242502422026-06-04
30680651424465Halyard42446NS42446NS2026-06-02
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10680651385250HalyardO&M HALYARD, INC.JCY2023-07-31
00884908175646TRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2023-06-17
50884908175641TRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2023-06-17
06974567743462EMSRUNWuxi Emsrun Technology Co., Ltd.JCY2022-12-06
00884908147056N/AN/AMedical Components, Inc.JCY2019-10-02
00884908147063N/AN/AMedical Components, Inc.JCY2019-10-02
00884908147070N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147051N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147068N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147075N/AN/AMedical Components, Inc.JCY2019-10-02
00884908146394INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146400INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146417INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146424INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146431INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146399INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146405INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146412INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146429INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146436INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908029048N/AN/AMedical Components, Inc.JCY2019-07-02
50884908029043N/AN/AMedical Components, Inc.JCY2019-07-02
00884908097009TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2017-03-16
50884908097004TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2017-03-16
04046964189555Blood Spike AdapterB. BRAUN MEDICAL INC.JCY2016-09-23