FDA.reportPublic FDA data

Additive

Primary DI
20887787001871
Brand
Additive
Company
HOSPIRA, INC.
Model
485801
Catalog number
0485801
Device description
LATEX-FREE ADDITIVE HINGE CAP LifeCare Flexible Container
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPECONTAINER, I.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887787001871PackageGS110In Commercial Distribution
10887787001874PrimaryGS10
M3354858011SecondaryHIBCC0
00887787001877Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088778700187120887787001871
1088778700187410887787001874
00887787001877008877870018778877870018770887787001877

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Controlled Room 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
100
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
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
20887787005466Lifeshield126482812648282016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00075289522178ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522185ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522192ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522208ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522215ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522222ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522239ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522246ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522253ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-10
18859299123612eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123629eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123636eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299124589eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
08056209145105EVA TPN BAGSVALMED SRLKPE2026-02-02
08056209145112EVA TPN BAGSVALMED SRLKPE2026-02-02
18033737862282EVA TPN BagsVALMED SRLKPE2025-12-31
10748426139726Medline-MicrotekMicrotek Medical LLCKPE2025-10-10
10748426139672Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
10748426139719Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
18859299136131eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136148eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136155eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
20192253056706ChemoPlusCardinal Health 200, LLCKPE2025-08-22
20192253056713ChemoPlusCardinal Health 200, LLCKPE2025-08-22
18859299136179eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-07-31
18859299136032eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136049eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136063eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136070eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136087eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06