AccessGUDID - DEVICE: Epimed (00818788020918)

GUDID

Device Identifier (DI) Information

Brand Name: Epimed
Version or Model: 134-1435
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 134-1435
Company Name: EPIMED INTERNATIONAL, INC

Primary DI Number: 00818788020918
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799751953 *Terms of Use

Device Description: Percutaneous Introducer w/ 14g RW x 2.7" B Bevel

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:	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?
62391	Non-vascular catheter introduction set	A collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MIA	NEEDLE, SPINAL, SHORT TERM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051860	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
Needle Gauge: 14 Gauge
Device Size Text, specify: 14g RW
Length: 3.5 Inch
Device Size Text, specify: 3.5"

Device Record Status

Public Device Record Key: b185f069-15ae-40a7-b121-23dc70998ff7
Public Version Date: March 20, 2024
Public Version Number: 4
DI Record Publish Date: October 30, 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
10818788020915	10	00818788020918		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: Yes
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)866-3342
Email: customerservice@epimed.com

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

FDA TOOLS & RESOURCES