Halyard

Primary DI
10680651927740
Brand
Halyard
Company
Avanos Medical, Inc.
Model
92774
Catalog number
60817
Device description
HALYARD* Injection Needle Catheter
Published
2016-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDHCATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDHCatheter (Gastric, Colonic, Etc.), Irrigation And AspirationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951533000EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITBallard Medical Products1995-07-05KDH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651927744PackageGS110In Commercial Distribution
10680651927740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065192774430680651927744
1068065192774010680651927740

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation catheter, single-lumenA flexible tube used to introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single-lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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

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