FDA.reportPublic FDA data

NA

Primary DI
06950456323229
Brand
NA
Company
Hangzhou Tappa Medical Technology Co., Ltd.
Model
WB-2101-N
Catalog number
WB-2101-N
Device description
Pediatric Full-Body Blanket
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K262089000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262089000Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.2026-08-21DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16950456323226PackageGS110In Commercial Distribution
26950456323223PackageGS14In Commercial Distribution
06950456323229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695045632322616950456323226
2695045632322326950456323223
06950456323229069504563232296950456323229

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-air core temperature regulation system pad, single-useAn underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit (not included). The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device.

Regulatory Flags#

DUNS number
530863352
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950456323090NAWB-1101-NWB-1101-N2026-09-30
06950456323106NAWB-1102-NWB-1102-N2026-09-30
06950456323113NAWB-1103-NWB-1103-N2026-09-30
06950456323120NAWB-1104-NWB-1104-N2026-09-30
06950456323137NAWB-1105-NWB-1105-N2026-09-30
06950456323144NAWB-1106-NWB-1106-N2026-09-30
06950456323151NAWB-1107-NWB-1107-N2026-09-30
06950456323168NAWB-1109-NWB-1109-N2026-09-30
06950456323175NAWB-1110-NWB-1110-N2026-09-30
06950456323182NAWB-1111-NWB-1111-N2026-09-30
06950456323199NAWB-1113-NWB-1113-N2026-09-30
06950456323205NAWB-1114-NWB-1114-N2026-09-30
06950456323212NAWB-1115-NWB-1115-N2026-09-30
06950456323236NAWB-2102-NWB-2102-N2026-09-30
06950456323243NAWB-1201-NWB-1201-N2026-09-30
06950456323250NAWB-1202-NWB-1202-N2026-09-30
06950456323267NAWB-1203-NWB-1203-N2026-09-30
06950456323274NAWB-1204-NWB-1204-N2026-09-30
06950456323281NAWB-1205-NWB-1205-N2026-09-30
06950456323298NAWB-1206-NWB-1206-N2026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323106NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323113NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323120NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323137NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323144NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323151NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323168NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323175NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323182NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323199NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323205NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323212NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323236NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323243NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323250NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323267NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323274NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323281NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323298NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323304NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323311NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323328NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323335NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323342NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323359NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323366NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323373NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323380NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323397NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30