FDA.report

PEMCO INC

Primary DI
B1521450150
Brand
PEMCO INC
Company
PEMCO INC
Model
1450-15
Catalog number
1450-15
Device description
Pediatric Intracardiac Sucker Tip - 6.4 mm diameter. Tips are grooved and slotted to allow for better flow and prevent clogging. For use with the Rou
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DTSSucker, Cardiotomy Return, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B1521450150PrimaryHIBCC0

GMDN Terms

TermDefinition
Suction cannula, reusableA rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter6.4Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
12165242990info@pemcomed.com

Regulatory Flags

DUNS number
004217071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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B152410028CS0RULTRACT4100-28CS4100-28CS2021-12-06
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B152410032AL0RULTRACT4100-32AL4100-32AL2021-12-06
B152410032ALS0RULTRACT4100-32ALS4100-32ALS2021-12-06
B152410032AP0RULTRACT4100-32AP4100-32AP2021-12-06
B152410032AS0RULTRACT4100-32AS4100-32AS2021-12-06
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38033178018747Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
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00842962106426HNM MedicalHNM STAINLESS, LLC.DTS2024-02-09
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05060660971749TEMEDTemedDTS2023-06-14
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