AccessGUDID - DEVICE: XTRA (08033178114738)

GUDID

Device Identifier (DI) Information

Brand Name: XTRA
Version or Model: 1/4-20 ft AAL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SORIN GROUP ITALIA SRL

Primary DI Number: 08033178114738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 442126587 *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):	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?
66788	Autotransfusion system aspiration/anticoagulation tubing set	A collection of flexible, noninvasive, double-lumen tubing and associated items (e.g., connector, clamp, spike) intended to both: 1) enable aspiration (suction) of blood from a patient to an appropriate container; and 2) deliver an anticoagulant solution to the aspirated blood, as part of an autotransfusion procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAC	Apparatus, autotransfusion
DTN	Reservoir, blood, cardiopulmonary bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241236	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd90a470-b8e5-4d09-aa70-78b49f462bcc
Public Version Date: December 30, 2024
Public Version Number: 1
DI Record Publish Date: December 20, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
38033178114739	15	18033178114735		In Commercial Distribution	BOX
18033178114735	3	08033178114738		In Commercial Distribution	BOX

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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