FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506088520
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
52000-03SM
Catalog number
52000-03SM
Device description
SMOOTH INFUSION CATHETER ADAPTER WITH STRAIGHT FEMALE LUER LOCK
Published
2026-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506088520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506088520001985060885201985060885200198506088520

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, reusableA collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506092183ELMED INCORPORATEDST5352077ST53520772026-07-29
00198506092343ELMED INCORPORATEDST5501380MST5501380M2026-07-29
00198506092350ELMED INCORPORATEDST3510800800ST35108008002026-07-29
00198506092640ELMED INCORPORATEDSTST5250541STST52505412026-07-29
00198506093197ELMED INCORPORATEDST7511814ST75118142026-07-29
00198506093487ELMED INCORPORATEDST233985ST2339852026-07-29
00198506093494ELMED INCORPORATEDST231006TST231006T2026-07-29
00198506093500ELMED INCORPORATEDST234215SSST234215SS2026-07-29
00198506093517ELMED INCORPORATEDST235066ST2350662026-07-29
00198506093524ELMED INCORPORATEDST231875DST231875D2026-07-29
00198506093531ELMED INCORPORATEDST234558ST2345582026-07-29
00198506093548ELMED INCORPORATEDST235930ST2359302026-07-29
00198506093555ELMED INCORPORATEDST23742503ST237425032026-07-29
00198506093562ELMED INCORPORATEDST5250223ST52502232026-07-29
00198506093579ELMED INCORPORATEDSTF9932 FSTF9932 F2026-07-29
00198506093586ELMED INCORPORATEDST1109400ST11094002026-07-29
00198506093593ELMED INCORPORATEDST420958ST4209582026-07-29
00198506093609ELMED INCORPORATEDST3315705ST33157052026-07-29
00198506093616ELMED INCORPORATEDST3380118ST33801182026-07-29
00198506093630ELMED INCORPORATEDST3155NUTST3155NUT2026-07-29

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00848657077958AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
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00198506086489ELMED INCORPORATEDELMED INCORPORATEDNWV2025-11-05