AccessGUDID - DEVICE: SURFLO (34806017510184)

GUDID

Device Identifier (DI) Information

Brand Name: SURFLO
Version or Model: SR-OX1851CA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TERUMO (PHILIPPINES) CORPORATION

Primary DI Number: 34806017510184
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 718848773 *Terms of Use

Device Description: SURFLO IV Catheter

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?
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133280	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
Special Storage Condition, Specify: Fragile. Handle with care. Keep dry. Keep away from sunlight.
Special Storage Condition, Specify: Do not store at extreme temperature and humidity.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Flow rate: 90 mL/min
Device Size Text, specify: 18 Catheter Gauge
Length: 2 Inch

Device Record Status

Public Device Record Key: b53689b9-62f7-4542-ba8a-25eec943cdac
Public Version Date: August 25, 2023
Public Version Number: 4
DI Record Publish Date: September 14, 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
74806017510182	10	54806017510188		In Commercial Distribution	Outer Carton
54806017510188	4	34806017510184		In Commercial Distribution	Inner Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 14806017510180 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: +1(800)283-7866
Email: tmccustomer.admin@terumomedical.com

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