AccessGUDID - DEVICE: WalkMed® (00859695006039)

GUDID

Device Identifier (DI) Information

Brand Name: WalkMed®
Version or Model: 204383
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FPS-560
Company Name: Walkmed Infusion LLC

Primary DI Number: 00859695006039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 948594726 *Terms of Use

Device Description: Pump Tubing Set with 0.2 micron filter for WalkMed Infusion Pump, 170 cm

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
FPB	Filter, Infusion Line
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
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -34.4 and 54.4 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Pore Size: 0.2 Micrometer
Length: 170 Centimeter

Device Record Status

Public Device Record Key: 997a5c05-0164-4467-a958-ac829833b663
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 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
10859695006036	10	00859695006039		In Commercial Distribution	Case Package of 10

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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: 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: 303-420-9569
Email: walkmedquality@walkmed.net

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