AccessGUDID - DEVICE: Sil-Flex (04710810083303)

GUDID

Device Identifier (DI) Information

Brand Name: Sil-Flex
Version or Model: 77015
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GaleMed Xiamen Co., Ltd.

Primary DI Number: 04710810083303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 527333326 *Terms of Use

Device Description: Sil-Flex tube 10F/22F，14cm

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:	No
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?
46819	Breathing circuit catheter mount, reusable	A device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end which may have a suction port included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZO	Set, Tubing And Support, Ventilator (W Harness)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a276345-b71f-4bad-ad8d-bb4d1cd32057
Public Version Date: September 09, 2020
Public Version Number: 3
DI Record Publish Date: September 19, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
44710810083301	4	24710810083307		In Commercial Distribution	Carton
24710810083307	50	04710810083303		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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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