FDA.reportPublic FDA data

Sapphire

Primary DI
20887787007378
Brand
Sapphire
Company
HOSPIRA, INC.
Model
1636402
Catalog number
1636402
Device description
SAPPHIRE Female Luer PCA Set KVO Y-Extension, Microbore, 114 Inch
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887787007378PackageGS150In Commercial Distribution
10887787007371PrimaryGS10
M33516364020SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088778700737820887787007378
1088778700737110887787007371

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
Length114Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
141588017
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
M3351239104251Plum1239125123912017-10-04
M3352079204251Plum2079225207922017-10-04
M3353001004051Plum 36030010300102017-10-04
10887787001751MedNet6.20.011603764042016-09-01
20887787001833VisIV101330310133032016-12-02
20887787001871Additive48580104858012016-09-20
20887787003011Plum142612814261282016-09-01
20887787003714Lifeshield126512812651282016-09-01
20887787003721Lifeshield126552812655282016-09-01
20887787003738Lifeshield126562812656282016-09-01
20887787003769Lifeshield206532820653282016-09-01
20887787005022Lifeshield040640104064012016-09-01
20887787005046Lifeshield064572806457282016-09-01
20887787005121Lifeshield114022811402282016-09-01
20887787005138Lifeshield114150511415052016-09-01
20887787005152Lifeshield117422811742282016-09-01
20887787005206Lifeshield120532812053282016-09-01
20887787005213Lifeshield122412812241282016-09-01
20887787005275Lifeshield123332812333282016-09-01
20887787005336Lifeshield123540512354052016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
10840365902093InvenioGRI Medical & Electronic Technology Co., Ltd.MRZ2025-03-12
07290109155296Sapphire PCA Lockbox 500mL Label EITAN MEDICAL LTDMRZ2024-11-29
15019517375244CADDSmiths Medical ASD, Inc.MRZ2024-10-14
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
27290109151650PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
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
27290109154705Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05
27290109152251AvosetPadEITAN MEDICAL LTDMRZ2023-08-09
27290109152275Avoset AAP Cradle EITAN MEDICAL LTDMRZ2023-08-09
17290109152292Avoset AAP Cassette Lock USEITAN MEDICAL LTDMRZ2023-08-09
B553HLTHOPTIMIZER170Health OptimizerWELLDOC, INC.MRZ2023-07-21
B553HLTHOPTIMIZERRX170Health Optimizer RxWELLDOC, INC.MRZ2023-07-21
B553HLTHOPTIMIZER160Health Optimizer WELLDOC, INC.MRZ2023-04-11
B553HLTHOPTIMIZERRX160Health Optimizer RxWELLDOC, INC.MRZ2023-04-11
27290109154309Sapphire ConnectEITAN MEDICAL LTDMRZ2023-03-26
27290109154491Sapphire Connect Power SupplyEITAN MEDICAL LTDMRZ2023-03-26
B553HLTHOPTIMIZER150Health Optimizer WELLDOC, INC.MRZ2023-01-10
B553HLTHOPTIMIZERX150Health Optimizer RxWELLDOC, INC.MRZ2023-01-10
17290109153985Infusion Pouch 500mLQ-CORE MEDICAL LTDMRZ2022-11-06