FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709035331
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
Z7023
Catalog number
Z7023
Device description
Clave™ Spike w/Vented Cap (Wet)
Published
2021-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082836000ICU MEDICAL UNIVERSAL SINGLE-USE SPIKESIcu Medical, Inc.2009-02-25FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709035338PackageGS150In Commercial Distribution
00887709035331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770903533810887709035338
00887709035331008877090353318877090353310887709035331

GMDN Terms#

Term, Definition table
TermDefinition
Luer-formatted bag access spikeA small, noninvasive, tubular connector with a Luer connection (either lock or slip) at one end, and a hollow spike (either blunt or sharp) at the other end, intended to connect an intravenous (IV) fluid or blood bag to a fluid line or syringe for administration to a patient; it may in addition be used to draw medication from a vial, however it is not a vial/bottle adaptor. It may include an additional administration port (i.e., Y-site device), a built-in air filter, retention clamp, or valve(s); it does not however include tubing (i.e., not a tubing set). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

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
10887709198033BivonaFT26GN40NGE057N2026-07-13
10887709198040BivonaXA26GS70NSC058N2026-07-13
10887709198057BivonaFT26GN35NGE060N2026-07-13
10887709198071BivonaFT26GN60NSC063N2026-07-13
10887709198088BivonaFT26GN45NGF056N2026-07-13
10887709198125BivonaFT26GN35NSE071N2026-07-13
10887709198132BivonaFT26GN35NSE072N2026-07-13
10887709197814BivonaSU26EN50NSF192S2026-07-10
10887709197821BivonaFT26GN35NSE028N2026-07-10
10887709197913BivonaFU26GN50NGF047N2026-07-10
10887709197920BivonaFU26GN50NGF049N2026-07-10
10887709197944BivonaFT26GN70NSD050N2026-07-10
10887709197951BivonaFU26GN45NGF051N2026-07-10
10887709197968BivonaXT26GS80NSC052N2026-07-10
10887709197975BivonaFT26GN30NGE053N2026-07-10
10887709197982BivonaFT26GN40NGE054N2026-07-10
10887709197999BivonaFA26GN80NSC055N2026-07-10
10887709198002BivonaHU26GS45NSC040N2026-07-10
10887709198019BivonaFT26GN40NSE041N2026-07-10
10887709198026BivonaFU26GN35NGF048N2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01