FDA.report

Sapphire

Primary DI
20887787007293
Brand
Sapphire
Company
HOSPIRA, INC.
Model
1632702
Catalog number
1632702
Device description
SAPPHIRE Primary Set CLAVE Y-Site, 116 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

Related Records

Contact Domains

Product Codes

CodeName
MRZACCESSORIES, PUMP, INFUSION

Product Code Classifications

CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20887787007293PackageGS150In Commercial Distribution
10887787007296PrimaryGS10
M33516327020SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088778700729320887787007293
1088778700729610887787007296

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length116Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature. Avoid Excessive Heat. Protect from Freezing

Sterilization Methods

Method

Contacts

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

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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

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B553HLTHOPTIMIZERX150Health Optimizer RxWELLDOC, INC.MRZ2023-01-10
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