FDA.report

Lifecare PCA

Primary DI
20887787005459
Brand
Lifecare PCA
Company
HOSPIRA, INC.
Model
1427728
Catalog number
1427728
Device description
Y-Type Minibore PCA Set, Integral PAV, Injector Assembly, Secure Lock, 67 Inch
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

Related Records

Contact Domains

Product Codes

CodeName
MEAPump, infusion, pca

Product Code Classifications

CodeDeviceSpecialtyClass
MEAPump, Infusion, PcaGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20887787005459PackageGS150In Commercial Distribution
10887787005452PrimaryGS10
M33514277280SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088778700545920887787005459
1088778700545210887787005452

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
Length67Inch

Storage And Handling

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

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)946-7747CustomerCare@hospira.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

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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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