AccessGUDID - DEVICE: AIV (M745FM10841)

GUDID

Device Identifier (DI) Information

Brand Name: AIV
Version or Model: FM10841
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FM10841
Company Name: AMERICAN IV PRODUCTS, INC.

Primary DI Number: M745FM10841
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 181184474 *Terms of Use

Device Description: Fetal Transducer Philips Toco

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?
37258	Tocodynamometer probe	A pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040392	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
Storage Environment Temperature: between 14 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 122.75 Inch
Height: 0.8 Inch
Outer Diameter: 2.75 Inch

Device Record Status

Public Device Record Key: fb32cde9-05a9-49cc-8917-b8b89e83ec90
Public Version Date: November 28, 2022
Public Version Number: 5
DI Record Publish Date: September 02, 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES