AccessGUDID - DEVICE: MediBag (00857595005732)

GUDID

Device Identifier (DI) Information

Brand Name: MediBag
Version or Model: 220524
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 220524
Company Name: SUMMIT MEDICAL PRODUCTS, INC.

Primary DI Number: 00857595005732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831704841 *Terms of Use

Device Description: MediBag - 250 mL with neuraxial connectors

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?
35188	Parenteral/enteral solution bag	A flexible pouch or sack designed to contain a solution of nutrients or medication for administration to a patient either parenterally (e.g., intravenously) or enterally (directly into the gastrointestinal tract). It is typically made of synthetic polymer materials. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KPE	Container, I.V.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001287	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 250 Milliliter

Device Record Status

Public Device Record Key: 7c47539b-2726-4969-be61-3d242293247d
Public Version Date: October 07, 2019
Public Version Number: 5
DI Record Publish Date: December 28, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20857595005736	60	10857595005739		In Commercial Distribution
10857595005739	30	00857595005732		In Commercial Distribution

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: 801-352-1888
Email: service@ambitpump.com

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