AccessGUDID - DEVICE: Uni-Flo (00857595005435)

GUDID

Device Identifier (DI) Information

Brand Name: Uni-Flo
Version or Model: 220491
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 220491
Company Name: SUMMIT MEDICAL PRODUCTS, INC.

Primary DI Number: 00857595005435
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831704841 *Terms of Use

Device Description: Uni-Flo™ Fenestrated Catheter – 10 inch (254mm), 19 GA x 36 in (914mm)

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):	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?
35795	Anaesthesia conduction catheter	A flexible tube intended to be percutaneously introduced for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management; it may be placed in the epidural space, into or around surgical wound sites, and near peripheral nerves. It may include devices dedicated to catheter introduction/function (e.g., needle, sheath); it is not coated with an antimicrobial agent. This device is typically used during surgical or diagnostic procedures or for the temporary relief of chronic pain in the limbs, pelvis, abdomen, or lumbar spine. This is a single-use device intended to be used in a sterile condition.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, Infusion

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 254 Millimeter

Device Record Status

Public Device Record Key: c1e8c21d-6fc9-431b-8314-971dbb054936
Public Version Date: February 07, 2019
Public Version Number: 6
DI Record Publish Date: September 09, 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
20857595005439	10	00857595005435		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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