AccessGUDID - DEVICE: HemaPrompt FG (00693501000152)

GUDID

Device Identifier (DI) Information

Brand Name: HemaPrompt FG
Version or Model: HPFG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AERSCHER, INC

Primary DI Number: 00693501000152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 926911454 *Terms of Use

Device Description: HemaPrompt FG Fecal and Gastric Test Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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?
54547	Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of biological fluids for the presence of occult blood within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHE	Reagent, Occult Blood

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972763	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
Handling Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ee0047f-f755-4c89-8735-eb6e5aa346b0
Public Version Date: November 09, 2022
Public Version Number: 4
DI Record Publish Date: August 05, 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: 00069350100015 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 410-778-2957
Email: wanda@hemaprompt.com

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