AccessGUDID - DEVICE: Tecotherm (05060206921740)

GUDID

Device Identifier (DI) Information

Brand Name: Tecotherm
Version or Model: TC-CRS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSPIRATION HEALTHCARE LIMITED

Primary DI Number: 05060206921740
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 734903532 *Terms of Use

Device Description: TC-CRS Fill-up set for Serial numbers 2015/24/01 and higher

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?
42841	Intravenous/irrigation solution storage container, reusable	An empty glass or plastic receptacle, capable of being sterilized, intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPF	BOTTLE, HOT/COLD WATER

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 157ac857-39dc-4052-800d-6f2a39e7228b
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: November 07, 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: 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

[?]

Phone: +441709361000
Email: info@inspiration-healthcare.com

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

FDA TOOLS & RESOURCES