AccessGUDID - DEVICE: Stool preparation system SAS (04050598010475)

GUDID

Device Identifier (DI) Information

Brand Name: Stool preparation system SAS
Version or Model: K 6998SAS.US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Immundiagnostik AG

Primary DI Number: 04050598010475
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 321663841 *Terms of Use

Device Description: No description.

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):	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?
65921	Faecal specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use for the sampling and containment of a small, predetermined amount of faecal matter from a primary faecal specimen, for subsequent laboratory analysis and/or other investigation. It typically consists of a specimen container (e.g., tube with a cap) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium, extraction buffer), and a sampling tool (e.g., swab, brush or spatula). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNK	Container, Specimen Mailer And Storage, Non-Sterile

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b253c3f-4d86-47d7-9367-a0170f264263
Public Version Date: June 29, 2023
Public Version Number: 1
DI Record Publish Date: June 21, 2023

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

[?]

No Customer Contact currently defined

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