FDA.reportPublic FDA data

Hospira

Primary DI
20887787008931
Brand
Hospira
Company
HOSPIRA, INC.
Model
1972128
Catalog number
1972128
Device description
LIFESHIELD LATEX FREE SOLUSET 150ML BURETTE, CONVERTIBLE PIERCING PIN DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VALVE, OPTION LOK NON-DEHP
Published
2016-09-01
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887787008931PackageGS120In Commercial Distribution
10887787008934PrimaryGS10
M33519721281SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088778700893120887787008931
1088778700893410887787008934

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose infusion pump, line-poweredA mains electricity (AC-powered) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers. The device has a typical flow range of 1 to 999 ml/hour and delivers solutions from a standard infusion bag or bottle of fluid. It typically has internal batteries that enable operation for a short period when no mains electricity is available (e.g., during transportation or a power outage).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length145Inch

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
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
20887787005343Lifeshield124190112419012016-09-01
20887787005428Lifeshield126424812642482016-09-01
20887787005435Lifeshield126452812645282016-09-01
20887787005442Lifeshield126462812646282016-09-01

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