AccessGUDID - DEVICE: Epimed International, Inc. (00818788021427)

GUDID

Device Identifier (DI) Information

Brand Name: Epimed International, Inc.
Version or Model: 181-2542
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 181-2542
Company Name: EPIMED INTERNATIONAL, INC

Primary DI Number: 00818788021427
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799751953 *Terms of Use

Device Description: Tun-L--XL™/24 19g X 24" w/ R.K.™ 16 TW X 3.5" w/ plastic LOR

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
34842	Epidural anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSO	CATHETER, CONDUCTION, ANESTHETIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954584	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 3.5 Inch
Needle Gauge: 16 Gauge
Length: 24 Inch
Catheter Gauge: 3.2 French
Device Size Text, specify: 16g
Device Size Text, specify: 3.2Ch
Device Size Text, specify: 3.5in
Device Size Text, specify: 24in

Device Record Status

Public Device Record Key: e7d174f5-1112-4627-9a5d-6e44353da0a5
Public Version Date: March 03, 2023
Public Version Number: 6
DI Record Publish Date: October 24, 2017