FDA.report

NA

Primary DI
20650862199257
Brand
NA
Company
ATRIUM MEDICAL CORPORATION
Model
19925
Device description
BULK PACK, REMOVABLE CLAMP (Drain Accessories)
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications

CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20650862199257PrimaryGS10
00650862199257Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2065086219925720650862199257
00650862199257006508621992576508621992570650862199257

GMDN Terms

TermDefinition
Medical tubing clip/clamp, non-calibrated, single-useA manual device designed to compress a piece of medical device tubing to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
051798999
Device count
100
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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