FDA.report

PEMCO INC

Primary DI
B15214600
Brand
PEMCO INC
Company
PEMCO INC
Model
1460
Catalog number
1460
Device description
Intracardiac Sucker: Flat, Pediatric Handle Fixed Tip, 3.2 mm diameter. Handle is 7.5 inches long with a 30 Degree Angle. Tips are grooved and slo
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
B15214600PrimaryHIBCC0

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
Angle30degree
Length7.5Inch
Outer Diameter3.2Millimeter

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
B152410032A0RULTRACT4100-32A4100-32A2021-12-06
B152410032AL0RULTRACT4100-32AL4100-32AL2021-12-06
B152410032ALS0RULTRACT4100-32ALS4100-32ALS2021-12-06
B152410032AP0RULTRACT4100-32AP4100-32AP2021-12-06
B152410032AS0RULTRACT4100-32AS4100-32AS2021-12-06
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