ICU Medical

Primary DI
10840619053205
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
CH-73
Catalog number
CH-73
Device description
13mm Vented Vial Spike with Tritan
Published
2021-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMGStopcock, i.V. Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMGStopcock, I.V. SetGeneral 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
10840619053205PackageGS150In Commercial Distribution
00840619053208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061905320510840619053205
00840619053208008406190532088406190532080840619053208

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02
10887709194738BivonaFP26FN35NSA007N2026-06-02
10887709194745BivonaFT26FN35NGE008N2026-06-02
10887709194752BivonaHT26FS85NSC009N2026-06-02
10887709194769BivonaFT26FN40NGF012N2026-06-02
10887709194776BivonaFT26FN35NSE011N2026-06-02
10887709194783BivonaXT26FS50NSA010N2026-06-02
10887709193830BivonaZU26EN70NSC132N2026-06-01
10887709193847BivonaZU26EN75NSC131N2026-06-01
10887709194257BivonaSP26EN40NGE157S2026-06-01
10887709194264BivonaFF26EN55NSF148S2026-06-01
10887709194271BivonaSU26EN45NGG150N2026-06-01
10887709194288BivonaFU26EN35NSF173N2026-06-01

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Primary DI, Brand, Company table
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00634624921160High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
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10193489896824Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMG2022-08-04
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