FDA.reportPublic FDA data

ICU Medical

Primary DI
00840619025816
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
CH-61
Catalog number
CH-61
Device description
Vial Adapter, 10-50 mL w/.22 Micron Vent, Clave™
Published
2021-07-27
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
K080989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080989000UNIVERSAL VIAL ACCESS SPIKEIcu Medical, Inc.2008-05-02FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619025813PackageGS150In Commercial Distribution
00840619025816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061902581310840619025813
00840619025816008406190258168406190258160840619025816

GMDN Terms#

Term, Definition table
TermDefinition
Vial/bottle adaptor, non-hermeticA device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. 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
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198873BivonaZU26GN75NSC099N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23
10887709199177BivonaFU26GN40NGA178N2026-07-23
10887709199184BivonaFU26GN55NSF173N2026-07-23
10887709199207BivonaST26GN50NSC177N2026-07-23
10887709199214BivonaFT26GN30NGF174N2026-07-23
10887709199221BivonaST26GN55NSC176N2026-07-23
10887709199238BivonaFT26GN40NGE175N2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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