AccessGUDID - DEVICE: Ameritus (10817522011769)

GUDID

Device Identifier (DI) Information

Brand Name: Ameritus
Version or Model: AEG-60P-90
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AEG-60P-90
Company Name: KENTEC MEDICAL, INC.

Primary DI Number: 10817522011769
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066175613 *Terms of Use

Device Description: 6fr 90cm feeding tube

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?
38561	Nasogastric/orogastric tube	A sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPD	Tube, Feeding

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100526	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 10 French

Device Record Status

Public Device Record Key: 902ac6cb-b363-463a-83de-25c96e27e04d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 29, 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
30817522011763	200	10817522011769		In Commercial Distribution	case
20817522011766	10	10817522011769		In Commercial Distribution	box

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 949-863-0810
Email: kjrooks@kentecmedical.com

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