FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
15019517065619
Brand
CARDINAL HEALTH
Company
ICU MEDICAL, INC.
Model
ED12638-TB
Catalog number
ED12638-TB
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEGSYRINGE, ANTISTICK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063755000PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGESmiths Medical Asd, Inc.2007-02-27MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019517065613PackageGS1100In Commercial Distribution
55019517065617PackageGS1600In Commercial Distribution
15019517065619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951706561335019517065613
5501951706561755019517065617
1501951706561915019517065619

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709203263BivonaFT26IN40NGE030N2026-09-04
10887709203270BivonaXT26IS70NSC031N2026-09-04
10887709203287BivonaFT26IN40NSF032N2026-09-04
10887709203294BivonaFT26IN50NSF034N2026-09-04
10887709203300BivonaFT26IN55NSF033N2026-09-04
10887709203324BivonaFT26IN30NSE036N2026-09-04
10887709201641BivonaZT26DN50NSZ214S2026-08-27
10887709202174BivonaST26HN80ZSZ137N2026-08-27
10887709202426BivonaFT26HN45NSF207N2026-08-27
10887709202433BivonaFU26HN40NGF213N2026-08-27
10887709202440BivonaFT26HN45NGA211N2026-08-27
10887709202464BivonaFT26HN30NGE215N2026-08-27
10887709202471BivonaFT26HN35NGE214N2026-08-27
10887709202259BivonaFU26HN35NGA187N2026-08-26
10887709202266BivonaFT26HN35NGE188N2026-08-26
10887709202273BivonaFU26HN40NGA186N2026-08-26
10887709202280BivonaFT26HN35NGF189N2026-08-26
10887709202297BivonaFU26HN40NGF190N2026-08-26
10887709202303BivonaFT26HN40NSE076N2026-08-26
10887709202310BivonaFU26HN25NGE191N2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
08056999020248SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
08056999020255SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
08056999020262SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
10840330704868ProCureTwin Med, LLCMEG2026-05-27
10840330704875ProCureTwin Med, LLCMEG2026-05-27
10840330705544ProCureTwin Med, LLCMEG2026-05-27
10840330705551ProCureTwin Med, LLCMEG2026-05-27
10840330705568ProCureTwin Med, LLCMEG2026-05-27
08800052609204"SHINA SAFETY SYRINGE 1.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609211"SHINA SAFETY SYRINGE 1.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609228"SHINA SAFETY SYRINGE 3.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609235"SHINA SAFETY SYRINGE 3.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
09347144013093Metier MedicalMETIER MEDICAL LTDMEG2025-07-08
10850053289627SURGYCOSurgyco LLCMEG2024-08-09
10850053289634SURGYCOSurgyco LLCMEG2024-08-09
10850053289641SURGYCOSurgyco LLCMEG2024-08-09
10850053289665SURGYCOSurgyco LLCMEG2024-08-09
10885380184703MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184987MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184994MonojectCardinal Health 200, LLCMEG2024-03-26
10193489037869MedlineMEDLINE INDUSTRIES, INC.MEG2024-02-01
10612479268705McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27