FDA.reportPublic FDA data

Halyard

Primary DI
30680651926778
Brand
Halyard
Company
Avanos Medical, Inc.
Model
92677
Catalog number
60435
Device description
HALYARD* Paracentesis Kit
Published
2016-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030721000QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical Products2003-03-31LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651926778PackageGS15In Commercial Distribution
10680651926774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065192677830680651926778
1068065192677410680651926774

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
false
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
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31
00812120005120Game Ready* Ankle Wrap, Extra Large120008550590340-042026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, Right120008551590422-042026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, Left120008552590424-042026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, Right120008553590432-042026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, Left120008554590434-042026-07-31
00812120005175Game Ready* Back Wrap120008555590500-042026-07-31
00812120005182Game Ready* C-T Spine Wrap, Large120008556590502-042026-07-31
00812120005199Game Ready* Hip/Groin Wrap, Right120008557590602-042026-07-31
00812120005205Game Ready* Hip/Groin Wrap, Left120008558590604-042026-07-31
00812120005212Game Ready* Hand/Wrist Wrap120008559590811-042026-07-31
00812120005229Game Ready* Flexed Elbow Wrap120008560590903-042026-07-31
00812120005236Game Ready* Half Leg Boot Wrap120008561590906-042026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, Large120008562590922-042026-07-31
00812120005250Game Ready* Straight Knee Sleeve120009290510100-042026-07-31
00812120005267Game Ready* Articulated Knee Sleeve120009291510160-042026-07-31
00812120005274Game Ready* Straight Elbow Sleeve120009292510200-042026-07-31
00812120005281Game Ready* Ankle Sleeve, Large120009293510330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528488HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528518HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528525HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528532HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528549HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528556HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528570HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528594HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528617HalyardAVID MEDICAL, INC.LRO2026-08-03
10885632528620SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-03
B098AMS16817B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS17579A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178970Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS191170Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
10809160528341HALYARDAVID MEDICAL, INC.LRO2026-08-01
10198956352315CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956364998CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956395503CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956453180CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956485358CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31