AccessGUDID - DEVICE: Tech Medical Services (00851695005036)

GUDID

Device Identifier (DI) Information

Brand Name: Tech Medical Services
Version or Model: TM500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECHMEDICAL SERVICES, INC.

Primary DI Number: 00851695005036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556093219 *Terms of Use

Device Description: Scope warmer which pre-warms multiple endoscopes

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):	No
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?
63518	Instrument warmer, exothermic chemical	A sterile heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of an envelope that is wrapped around the instrument (e.g., laparoscope), and filled with a material which produces an exothermic chemical reaction when activated. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWV	Laparoscopic Accessories, Gynecologic

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: 4e43eec0-f675-4acd-9dd4-7d07ed97dc82
Public Version Date: May 10, 2021
Public Version Number: 4
DI Record Publish Date: October 13, 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
10851695005033	10	00851695005036		In Commercial Distribution

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

Customer Contact

[?]

No Customer Contact currently defined

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