AccessGUDID - DEVICE: AESCULAP (04038653396405)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: FH600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FH600
Company Name: Aesculap AG

Primary DI Number: 04038653396405
Issuing Agency: GS1
Commercial Distribution End Date: November 11, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: MINOP TR FOOT CONTR.F.TUBE SET FH602

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:	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?
15896	General-purpose casework	Furniture consisting of different units, e.g., cabinets, shelves, racks, worktops, combined and installed in a healthcare facility to provide users with a general-purpose functional work and storage place. This will also separate the floor/room area creating a practical discrete working environment for the staff. The units are used to store materials, supplies, devices, records, samples, and other items. This furniture is usually modular and constructed using thicker panels and more long-lasting surface finishes than ordinary office/domestic furniture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAZ	TUBING, NONINVASIVE

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8697d0f7-3565-4268-8f9c-945332388907
Public Version Date: January 19, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 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
No Package DIs found

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)282-9000
Email: GUDID.BBMUS_Service@bbraun.com

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