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
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® Connector120004842BP-S12NC2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® Connector120004847BP-S60NC2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004849NEO122026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004852NEO602026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® Connector120004832BA-S12NC-S2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® Connector120004869PNM-S12NC2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® Connector120004874PNM-S35NC2026-08-15
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537855HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537862HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537879HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537886HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537893HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537909HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537916HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537923HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537930HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537947HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537954HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537961HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537985HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537992HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538005HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538029HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538036HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538043HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537541HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537558HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537572HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537589HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537596HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537602HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537640HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537664HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537688HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537695HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537701HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537732HalyardAVID MEDICAL, INC.LRO2026-09-19