AccessGUDID - DEVICE: Primary Sets (10887787009290)

GUDID

Device Identifier (DI) Information

Brand Name: Primary Sets
Version or Model: B947301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B947301
Company Name: ICU Medical, Inc.

Primary DI Number: 10887787009290
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830767898 *Terms of Use

Device Description: Primary MICRODRIP Set 2 CLAVE Y-Sites, 100 Inch, Non-DEHP

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?
58977	Basic intravenous administration set, noninvasive	A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. 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 [?]
K142367	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: Room Temperature. Avoid Excessive Heat. Protect from Freezing

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Inch
Device Size Text, specify: Approximate priming volume : 16 Milliliter
Device Size Text, specify: Drop Size : 60 Drops / Milliliter

Device Record Status

Public Device Record Key: 38df66fb-6fbf-401d-b3c2-58b350115d68
Public Version Date: October 17, 2025
Public Version Number: 5
DI Record Publish Date: June 04, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20887787009297	50	10887787009290		In Commercial Distribution	Corrugated Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	M335B9473010

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: +1(877)946-7747
Email: uscustomercare@icumed.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES