AccessGUDID - DEVICE: GUARDIVA (00801741085826)

GUDID

Device Identifier (DI) Information

Brand Name: GUARDIVA
Version or Model: FP-24-AD012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP-24-AD012
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741085826
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: GUARDIVA 1IN/ 7MM STERILE

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:	Yes
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?
65042	Percutaneous catheter protector, professional	A dressing-like device intended to be used by a healthcare professional to cover and protect a percutaneous access cannula/catheter site (typically intravenous) to manage and help prevent complications (e.g., leakage, bleeding, infection). It is available in a variety of designs which may include a foam pad intended to absorb exudates/blood and a transparent shield that allows observation, sometimes with holes for ventilation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, wound, drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4999c1b9-b7e8-44d8-9e85-fbb0fbf45964
Public Version Date: November 25, 2024
Public Version Number: 3
DI Record Publish Date: November 09, 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
10801741085823	10	00801741085826		In Commercial Distribution	Shelfpack
20801741085820	10	10801741085823		In Commercial Distribution	Case

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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