AccessGUDID - DEVICE: Hospira (10887787006657)

GUDID

Device Identifier (DI) Information

Brand Name: Hospira
Version or Model: 469301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 469301
Company Name: HOSPIRA, INC.

Primary DI Number: 10887787006657
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141588017 *Terms of Use

Device Description: LATEX-FREE EXTENSION SET

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
34930	Single-administration urethral drainage/irrigation catheter	A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

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
Device Size Text, specify: Approximate priming volume : 12 Milliliter
Length: 70 Inch

Device Record Status

Public Device Record Key: e70a9dba-1ec9-4331-a940-296778824b56
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
20887787006654	20	10887787006657		In Commercial Distribution	case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	M3354693010

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: uscustomercare@pfizer.com

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