FDA.reportPublic FDA data

SURFLO MIDELA

Primary DI
36927675520433
Brand
SURFLO MIDELA
Company
Terumo Medical Products (Hangzhou) Co., Ltd.
Model
MCSD001F
Catalog number
MCSD001F
Device description
SURFLO MIDELA Securement Device
Published
2026-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMKDevice, Intravascular Catheter Securement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
56927675520437PackageGS120In Commercial Distribution
36927675520433PrimaryGS10
06927675520432Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5692767552043756927675520437
3692767552043336927675520433
06927675520432069276755204326927675520432

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holder, single-useA noninvasive device designed to fix a percutaneous (excluding intracranial) catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, a base plate, strip, or bandage that will attach to the patient's skin, and may include holes to allow suture fixation. The exposed side may have integrated fixation mechanism to hold the catheter/tube in place and may include a transparent film portion intended for fixation site monitoring. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperatures.Fragile, handle with care. Keep away from sunlight. Keep dry .Stacking limit by 5.

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
544830912
Device count
20
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36927675517273SURFLO MIDELAMCS1810D01FMCS1810D01F2026-04-01
36927675517280SURFLO MIDELAMCS2010D00FMCS2010D00F2026-04-01
36927675517297SURFLO MIDELAMCS2208D01FMCS2208D01F2026-04-01
36927675517303SURFLO MIDELAMCS1810D00FMCS1810D00F2026-04-01
36927675517310SURFLO MIDELAMCS2208D00FMCS2208D00F2026-04-01
36927675519857SURFLO MIDELAMCS1808D00FMCS1808D00F2026-04-01
36927675519864SURFLO MIDELAMCS2008D00FMCS2008D00F2026-04-01
36927675520457SURFLO HYBRIASH18322332AFSH18322332AF2026-04-01
36927675520464SURFLO HYBRIASH18252332AFSH18252332AF2026-04-01
36927675520471SURFLO HYBRIASH20322332AFSH20322332AF2026-04-01
36927675520488SURFLO HYBRIASH20252332AFSH20252332AF2026-04-01
36927675520495SURFLO HYBRIASH22252332AFSH22252332AF2026-04-01
36927675520501SURFLO HYBRIASH22192332AFSH22192332AF2026-04-01
36927675520518SURFLO HYBRIASH24192332AFSH24192332AF2026-04-01
36927675520525SURFLO HYBRIASH18322320AFSH18322320AF2026-04-01
36927675520532SURFLO HYBRIASH18252320AFSH18252320AFF2026-04-01
36927675520549SURFLO HYBRIASH20322320AFSH20322320AF2026-04-01
36927675520556SURFLO HYBRIASH20252320AFSH20252320AF2026-04-01
36927675520563SURFLO HYBRIASH22252320AFSH22252320AF2026-04-01
36927675520570SURFLO HYBRIASH22192320AFSH22192320AF2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10618125192585Grip-LokTIDI PRODUCTS, LLCKMK2026-04-15
10816000014070ARROWTELEFLEX INCORPORATEDKMK2025-09-16
10801741082983StatLockBard Access Systems, Inc.KMK2025-05-02
10801741087582StatLockBard Access Systems, Inc.KMK2025-05-02
10816000013868ARROWTELEFLEX INCORPORATEDKMK2025-04-04
10618125192141Grip-LokTIDI PRODUCTS, LLCKMK2024-12-02
10885632416309HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-30
10885632416279HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416286HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416293HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10618125135148Grip-LokTIDI PRODUCTS, LLCKMK2024-04-22
20653160370694CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370700CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370717CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370724CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370731CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370748CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160371073CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-02-02
20653160369322MEDLINEMEDLINE INDUSTRIES, INC.KMK2023-12-01
30382905154035BD PhaSealBECTON DICKINSON PEN LIMITEDKMK2023-09-15
10686004000023UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000030UtraDressingI.V. House, Inc.KMK2023-07-21
10686004000054UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000320UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000013UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000303UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000310UltraDomeI.V. House, Inc.KMK2023-07-21
30686004000041UltraDressingI.V. House, Inc.KMK2023-07-21
20653160358692CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2023-02-06