FDA.reportPublic FDA data

PECO

Primary DI
10817668010558
Brand
PECO
Company
PECO MEDICAL INC.
Model
PU012P
Device description
"Box PECO™ 10"" Pediatric, 12 Fr. Straight Intermittent Catheter"
Published
2017-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBMCATHETER, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111405000BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,Hangzhou Bever Medical Devices Co., Ltd.2012-02-13GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817668010558PrimaryGS10
00817668010551Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081766801055810817668010558
00817668010551008176680105518176680105510817668010551

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length10Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080120792
Device count
30
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817668010015PECOPU0082017-09-08
10817668010022PECOPU0102017-09-08
10817668010039PECOPU0122017-09-08
10817668010046PECOPU0142017-09-08
10817668010053PECOPU0162017-09-08
10817668010060PECOPU0182017-09-08
10817668010077PECOPU010F2017-09-08
10817668010084PECOPU012F2017-09-08
10817668010091PECOPU014F2017-09-08
10817668010107PECOPU016F2017-09-08
10817668010114PECOPU018F2017-09-08
10817668010121PECOPU008F2017-09-08
10817668010503PECOPU0062017-09-08
10817668010510PECOPU006L2017-09-08
10817668010527PECOPU008L2017-09-08
10817668010534PECOPU010L2017-09-08
10817668010565PECOPU014P2017-09-08
10817668010572PECOPU014FN2017-09-08

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Primary DI, Brand, Company table
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