AccessGUDID - DEVICE: EXTENSION SET (00085412660387)

GUDID

Device Identifier (DI) Information

Brand Name: EXTENSION SET
Version or Model: 2N3386
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2N3386
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412660387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: Micro-Volume Catheter Extension Set with 0.2 micrometer Filter

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?
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular
FPB	Filter, infusion line

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192366	000

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: Store at Room Temperature, Keep dry, Keep away from sunlight (or heat)

Clinically Relevant Size

[?]

Size Type Text
Length: 250000000000000 Femtometer
Pore Size: 0.00000020 Meter
Pressure: 45 Pound per Square Inch
Total Volume: 0.44 Milliliter

Device Record Status

Public Device Record Key: 94370a5d-9b5a-45cc-81cc-a6b1c2d3b0ef
Public Version Date: July 19, 2023
Public Version Number: 3
DI Record Publish Date: September 30, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50085412660382	50	00085412660387		In Commercial Distribution	CASE

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)933-0303
Email: medinfo_medproducts@baxter.com

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