FDA.reportPublic FDA data

Medline

Primary DI
40884389181783
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDX41901
Catalog number
DYNDX41901
Device description
CATHETER,SUCTION,12FR,WHISTL,STR PK,CAL
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389181783PackageGS1100In Commercial Distribution
10884389181782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438918178340884389181783
1088438918178210884389181782

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat. Protect from freezing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)Dynarex CorporationBSY2026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)Dynarex CorporationBSY2026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)Dynarex CorporationBSY2026-05-25
20889483623562BALLARD™SUNMED, LLCBSY2026-01-16
00840117344136Resp-O2 Vortex 72 Closed Suction Tracheal Catheter,30.5 cm/12in, 12 FR (4.0 mm) Dynarex CorporationBSY2026-01-05
00840117344143Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344150Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 16 FR (5.3 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344167Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR (3.3 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344174Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 12 FR (4.0 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344181Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344198Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 16 FR (5.3 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
30889483563605BALLARD™SUNMED, LLCBSY2025-12-02
30889483563131BALLARD™SUNMED, LLCBSY2025-12-01
30889483563155BALLARD™SUNMED, LLCBSY2025-12-01
30889483563384BALLARD™SUNMED, LLCBSY2025-12-01
30889483563421BALLARD™SUNMED, LLCBSY2025-12-01
30889483564602BALLARD™SUNMED, LLCBSY2025-11-24
30889483564633BALLARD™SUNMED, LLCBSY2025-11-24
30889483564640BALLARD™SUNMED, LLCBSY2025-11-24
30889483564701BALLARD™SUNMED, LLCBSY2025-11-24
30889483564718BALLARD™SUNMED, LLCBSY2025-11-24
30889483564824BALLARD™SUNMED, LLCBSY2025-11-24
30889483567009BALLARD™SUNMED, LLCBSY2025-11-24
30889483623507BALLARD™SUNMED, LLCBSY2025-11-24
30889483623514BALLARD™SUNMED, LLCBSY2025-11-24
30889483626591BALLARD™SUNMED, LLCBSY2025-11-24
30889483562615BALLARD™SUNMED, LLCBSY2025-11-21
30889483623316BALLARD™SUNMED, LLCBSY2025-11-21
30889483623323BALLARD™SUNMED, LLCBSY2025-11-21
30889483623347BALLARD™SUNMED, LLCBSY2025-11-21