FDA.reportPublic FDA data

Sapphire

Primary DI
10887787007302
Brand
Sapphire
Company
ICU Medical, Inc.
Model
1633202
Catalog number
1633202
Device description
SAPPHIRE Primary 0.2 Micron Filter Set CLAVE Y-Site, 112 Inch (previously Hospira product)
Published
2018-06-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRZACCESSORIES, PUMP, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171346000Sapphire SetsIcu Medical2017-08-25MRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887787007309PackageGS150In Commercial Distribution
10887787007302PrimaryGS10
M33516332020SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088778700730920887787007309
1088778700730210887787007302

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length112Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature. Avoid Excessive Heat. Protect from Freezing

Contacts#

Phone, Email table
PhoneEmail
+1(877)946-7747uscustomercare@icumed.com

Regulatory Flags#

DUNS number
830767898
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
10887709198385BivonaXZ26GS70NSC058N2026-08-03
10887709198866BivonaFU26GN40NSZ134N2026-08-03
10887709198880BivonaXU26GS55NGZ141N2026-08-03
10887709199368BivonaZT26GN95ZSZ155N2026-08-03
10887709199580BivonaFT26GN45NSE190N2026-08-03
10887709199641BivonaSA26GN80ZSZ135N2026-08-03
10887709199764BivonaXU26GS60NSA218N2026-08-03
10887709199771BivonaFU26GN55NSF216N2026-08-03
10887709199788BivonaXU26GS60NSA217N2026-08-03
10887709199801BivonaFU25GN65NSD167N2026-08-03
10887709199818BivonaSU26GN50NGF219N2026-08-03
10887709199825BivonaFU26GN45NSC211N2026-08-03
10887709199832BivonaFU26GN45NGF214N2026-08-03
10887709199849BivonaFU26GN35NSE226N2026-08-03
10887709199856BivonaFU26GN30NSE227N2026-08-03
10887709199863BivonaFT26GN40NSC233N2026-08-03
10887709200002BivonaFU26GN45NSF240N2026-08-03
10887709200019BivonaFT26GN55NGF246N2026-08-03
10887709200026BivonaFU26GN30NGA239N2026-08-03
10887709200033BivonaST26GN55NSC245N2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955582969Perfusor®B. BRAUN MEDICAL INC.MRZ2026-06-07
04046955739721SPACEB. BRAUN MEDICAL INC.MRZ2026-04-11
B553202291OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202292OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202293OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
00085412718378Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
00085412947914Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
00840365902096InvenioGri-Alleset, Inc.MRZ2025-03-12
10840365902093InvenioGRI Medical & Electronic Technology Co., Ltd.MRZ2025-03-12
07290109155296Sapphire PCA Lockbox 500mL Label EITAN MEDICAL LTDMRZ2024-11-29
15019517375244CADDICU MEDICAL, INC.MRZ2024-10-14
1729010915261250/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
17290109152629Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
2729010915261950/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
27290109152626Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
B553202191OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202192OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202193OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202091OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
B553202092OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
17290109151653PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
27290109151650PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
17290109154104Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
27290109154101Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
B553202093OTC0Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER190Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER180Health OptimizerWELLDOC, INC.MRZ2023-11-17
00850025535502UTC 3ml Medication CartridgeGilero, LLCMRZ2023-09-25
17290109154708Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05