AccessGUDID - DEVICE: Tarry Probes (00854758006049)

GUDID

Device Identifier (DI) Information

Brand Name: Tarry Probes
Version or Model: T 11000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T 11000
Company Name: TARRY MEDICAL PRODUCTS, INC.

Primary DI Number: 00854758006049
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107260002 *Terms of Use

Device Description: T 11000 Single Use Skin Temperature Probe

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
35254	General-purpose patient temperature probe, single-use	A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMZ	Incubator, Neonatal
FMT	Warmer, Infant Radiant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071977	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 41d029b8-f58e-4b39-bace-7005b7ba4215
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 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
20854758006043	100	00854758006049		In Commercial Distribution
10854758006046	25	00854758006049		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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 2037941438
Email: customerservice@tarrymfg.com

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

FDA TOOLS & RESOURCES