AccessGUDID - DEVICE: PECO (10817668010022)

GUDID

Device Identifier (DI) Information

Brand Name: PECO
Version or Model: PU010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PECO MEDICAL INC.

Primary DI Number: 10817668010022
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2020
Device Count: 30
Labeler D-U-N-S® Number*: 080120792 *Terms of Use

Device Description: Box PECO™ 10" Pediatric, 10 Fr. Straight Intermittent 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):	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?
45603	Single-administration urethral drainage catheter	A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBM	CATHETER, URETHRAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111405	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 10 French
Length: 10 Inch

Device Record Status

Public Device Record Key: 807d1841-6acd-473a-b088-0eba58ec6e0e
Public Version Date: August 17, 2021
Public Version Number: 4
DI Record Publish Date: September 08, 2017

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: 00817668010025 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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