FDA.reportPublic FDA data

ICU Medical

Primary DI
10887709078564
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
MC330123
Catalog number
MC330123
Device description
8" (20 cm) Appx 0.64 ml, Pressure Infusion (400psig) Ext Set w/2 MicroClave™ Clear (1 Remv), 2 Purple Clamps, Rotating Luer
Published
2021-08-24
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100576000HIGH PRESSURE SETS-400 PSIIcu Medical, Inc.2010-12-17FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709078564PackageGS150In Commercial Distribution
00887709078567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770907856410887709078564
00887709078567008877090785678877090785670887709078567

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. 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
10887709198163BivonaFU26GN40NGE068N2026-07-14
10887709198170BivonaFU26GN50NGC069S2026-07-14
10887709198187BivonaFT26GN60NSF067N2026-07-14
10887709198194BivonaSU26GN40NGF073N2026-07-14
10887709198200BivonaFU26GN40NGA064N2026-07-14
10887709198217BivonaFT26GN40NGF074N2026-07-14
10887709198224BivonaFT26GN45SSF075N2026-07-14
10887709198231BivonaFT26GN30NSE076N2026-07-14
10887709198248BivonaFT26GN40NSE077N2026-07-14
10887709198255BivonaFT26GN60NGF078N2026-07-14
10887709198262BivonaFP26GN35ASF079N2026-07-14
10887709198279BivonaFT26GN35NGE080N2026-07-14
10887709198286BivonaFT26GN35NGE081N2026-07-14
10887709198293BivonaHT26GS60NSC086N2026-07-14
10887709198309BivonaFT26GN40NGE082N2026-07-14
10887709198316BivonaFT26GN30NSE087N2026-07-14
10887709198323BivonaFT26GN35NSE088N2026-07-14
10887709198330BivonaFT26GN55NSF084N2026-07-14
10887709198033BivonaFT26GN40NGE057N2026-07-13
10887709198040BivonaXA26GS70NSC058N2026-07-13

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