AccessGUDID - DEVICE: Lifecare PCA (10887787005957)

GUDID

Device Identifier (DI) Information

Brand Name: Lifecare PCA
Version or Model: 1936101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1936101
Company Name: HOSPIRA, INC.

Primary DI Number: 10887787005957
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 141588017 *Terms of Use

Device Description: Yellow Cap for Use with Hospira PCA Vial

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35833	Electric infusion pump administration set, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEA	Pump, infusion, pca

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Room Temperature. Avoid Excessive Heat. Protect from Freezing

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f29c5ed-ccb6-4751-9bd4-6ea025093805
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20887787005954	20	10887787005957		In Commercial Distribution	Corrugated Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	M33519361010

Unit of Use DI

[?]

Unit of Use DI Number: 00887787005950 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)946-7747
Email: CustomerCare@hospira.com

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